No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 28031497001702 | ASC0020 | MENDEC AQUA is a sterile single-use device for extrusion into the bone of acryli MENDEC AQUA is a sterile single-use device for extrusion into the bone of acrylic resins or bone void fillers (not supplied with the kit) intended for vertebral augmentation procedures (vertebroplasty, kyphoplasty, screw-augmentation). | OAR | Injector, Vertebroplasty (Does Not Contain Cement) | 1 | MENDEC AQUA | |
2 | 28031497001429 | ASA0380 | Shakit is intended for mixing acrylic resins or bone void fillers components. | JDZ | Mixer, Cement, For Clinical Use | 1 | Shakit | |
3 | 28031497000132 | 1310/S | Cemex System 60g is a polymethylmethacrylate bone cement. Cemex System 60g holds Cemex System 60g is a polymethylmethacrylate bone cement. Cemex System 60g holds the powder (60g) and liquid (22g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system.The device is supplied sterile, for single use.Cemex System 60g is indicated for the fixation of joint prosthesis implants to the host bone. | LOD | Bone Cement | 2 | CEMEX SYSTEM 60G | |
4 | 08031497002897 | SPK90Z2 | InterSpace Knee ATS Trial Kit is intended to be used for the selection of the ri InterSpace Knee ATS Trial Kit is intended to be used for the selection of the right size and thickness of the InterSpace Knee ATS to be implanted. | HWT | Template | 1 | InterSpace Knee ATS Trial Kit | |
5 | 08031497002347 | SPK90Z1 | InterSpace Knee Trial is intended to be used for the selection of the right size InterSpace Knee Trial is intended to be used for the selection of the right size of InterSpace Knee to be implanted. | HWT | Template | 1 | InterSpace Knee Trial | |
6 | 08031497002101 | 110043026 | Conflow G Bone Cement is a low viscosity antibiotic-loaded polymethylmethacrylat Conflow G Bone Cement is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. Conflow G Bone Cement is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. | LOD,MBB | Bone Cement,Bone Cement, Antibiotic | 2 | Conflow G Bone Cement | |
7 | 08031497001470 | ASB0010 | BONE INJECTION NEEDLE beveled tip 11 Gauge 120 mm length with plastic handgrip i BONE INJECTION NEEDLE beveled tip 11 Gauge 120 mm length with plastic handgrip intended for the injection of acrylic resin. | KIH | Dispenser, Cement | 1 | BONE INJECTION NEEDLE beveled tip 11 Gauge 120 mm length | |
8 | 08031497001456 | ASC0000 | The device is an accessory intended to fill up to six needles or fillers with ac The device is an accessory intended to fill up to six needles or fillers with acrylic resins for vertebroplasty/kyphoplasty at the same time. | HXK | Holder, Needle; Orthopedic | 1 | Mendec V FILL | |
9 | 08031497000770 | ASB0090 | BONE INJECTION NEEDLE beveled tip 11 Gauge 120 mm length with metal handgrip int BONE INJECTION NEEDLE beveled tip 11 Gauge 120 mm length with metal handgrip intended for the injection of acrylic resin. | KIH | Dispenser, Cement | 1 | BONE INJECTION NEEDLE beveled tip 11 Gauge 120 mm length | |
10 | 28031497001870 | SPK0422 | Temporary Augmented Tibial Stem Spacer with gentamicin. Interspace Knee ATS is c Temporary Augmented Tibial Stem Spacer with gentamicin. Interspace Knee ATS is composed of fully formed gentamicin/polymethylmethacrylate (PMMA), radio-opaque bone cement. The device is sterile and single-use.InterSpace Knee ATS is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, and where a large tibial defect is present.InterSpace Knee ATS is applied on the tibial plate following removal of the existing implant and radical debridement. The device must be combined with the tibial component of InterSpace Knee. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).InterSpace Knee ATS is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device material (gentamicin/ polymethylmethacrylate), the Interspace Knee ATS is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period. | JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | Interspace Knee ATS 60/07 | |
11 | 08031497002903 | SPK03Z1 | InterSpace Knee Trial XL is intended to be used for the selection of the right s InterSpace Knee Trial XL is intended to be used for the selection of the right size of InterSpace Knee XL to be implanted. | HWT | Template | 1 | InterSpace Knee Trial XL | |
12 | 28031497000071 | 1220/I | Cemex Isoplastic 1/2 pack is a high viscosity polymethylmethacrylate bone cement Cemex Isoplastic 1/2 pack is a high viscosity polymethylmethacrylate bone cement. It is composed by two components (20g powder and 6.65g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use.Cemex Isoplastic 1/2 pack is indicated for the fixation of joint prosthesis implants to the host bone. | LOD | Bone Cement | 2 | CEMEX ISOPLASTIC 1/2 PACK | |
13 | 08031497002330 | 71271610 | RALLY ALL IN ONE CEMENT GUN is intended to be used for helping the extrusion (an RALLY ALL IN ONE CEMENT GUN is intended to be used for helping the extrusion (and hence the delivery) of the bone cement prepared with the RALLY ALL IN ONE SYSTEM devices. | KIH | Dispenser, Cement | 1 | RALLY All In One Cement Gun | |
14 | 08031497001999 | ASB0050 | Freezer ring is an accessory intended to be applied to the syringe of Mendec Spi Freezer ring is an accessory intended to be applied to the syringe of Mendec Spine Kit. It allows a longer extrusion time of the resin. | KDD | Kit, Surgical Instrument, Disposable | 1 | Freezer Ring | |
15 | 08031497000800 | ASB0120 | BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length with plastic handgrip i BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length with plastic handgrip intended for the injection of acrylic resin. | KIH | Dispenser, Cement | 1 | BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length | |
16 | 08031497000794 | ASB0110 | BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length with metal handgrip int BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length with metal handgrip intended for the injection of acrylic resin. | KIH | Dispenser, Cement | 1 | BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length | |
17 | 08031497000725 | SPN1512 | BONE INJECTION NEEDLE diamond tip 15 Gauge 120 mm length with plastic handgrip i BONE INJECTION NEEDLE diamond tip 15 Gauge 120 mm length with plastic handgrip intended for the injection of acrylic resin. | KIH | Dispenser, Cement | 1 | BONE INJECTION NEEDLE diamond tip 15 Gauge 120 mm length | |
18 | 28031497000033 | 1200/I | Cemex Isoplastic is a high viscosity polymethylmethacrylate bone cement. It is c Cemex Isoplastic is a high viscosity polymethylmethacrylate bone cement. It is composed by two components (40g powder and 13.3g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use.Cemex Isoplastic is indicated for the fixation of joint prosthesis implants to the host bone. | LOD | Bone Cement | 2 | CEMEX ISOPLASTIC | |
19 | 08031497002668 | SPZ-01 | FEMORAL BRUSH facilitates the removal of bone chips and tissue from the medullar FEMORAL BRUSH facilitates the removal of bone chips and tissue from the medullary canal. It is intended to be used for helping the surgeons, during the fixation of artificialjoint prosthesis with the acrylic bone cement, in cleaning the femoral canal from debris after the canal has been drilled and before the cement application. | GEC | Brush, Scrub, Operating-Room | 1 | FEMORAL BRUSH | |
20 | 08031497002095 | 110043025 | Conflow Bone Cement is a low viscosity polymethylmethacrylate bone cement. It is Conflow Bone Cement is a low viscosity polymethylmethacrylate bone cement. It is composed by two components (40g powder and 13,3g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. Conflow Bone Cement is indicated for the fixation of joint prosthesis implants to the host bone. | LOD | Bone Cement | 2 | Conflow Bone Cement | |
21 | 08031497000718 | SPN1312 | BONE INJECTION NEEDLE diamond tip 13 Gauge 120 mm length with plastic handgrip i BONE INJECTION NEEDLE diamond tip 13 Gauge 120 mm length with plastic handgrip intended for the injection of acrylic resin. | KIH | Dispenser, Cement | 1 | BONE INJECTION NEEDLE diamond tip 13 Gauge 120 mm length | |
22 | 28031497001436 | ASA0390 | XTRUDER is intended for extrusion of acrylic resins or bone void fillers prepare XTRUDER is intended for extrusion of acrylic resins or bone void fillers prepared with Tecres SHAKIT. | KIH | Dispenser, Cement | 1 | XTRUDER | |
23 | 28031497001900 | SPK0722 | Temporary Augmented Tibial Stem Spacer with gentamicin. Interspace Knee ATS is c Temporary Augmented Tibial Stem Spacer with gentamicin. Interspace Knee ATS is composed of fully formed gentamicin/polymethylmethacrylate (PMMA), radio-opaque bone cement. The device is sterile and single-use.InterSpace Knee ATS is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, and where a large tibial defect is present.InterSpace Knee ATS is applied on the tibial plate following removal of the existing implant and radical debridement. The device must be combined with the tibial component of InterSpace Knee. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).InterSpace Knee ATS is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device material (gentamicin/ polymethylmethacrylate), the Interspace Knee ATS is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period. | JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | Interspace Knee ATS 80/12 | |
24 | 28031497001382 | 13C2040 | Mendec Spine HV System is indicated for the treatment of pathological fractures Mendec Spine HV System is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure.Mendec Spine HV System is a closed sysyem which containes the powder and liquid components separately.The device is disposable and sterile. | LOD,NDN | Bone Cement,Cement, Bone, Vertebroplasty | 2 | Mendec Spine HV System | |
25 | 28031497000514 | 1500/SG US | Cemex Genta System 80g is an antibiotic-loaded polymethylmethacrylate bone cemen Cemex Genta System 80g is an antibiotic-loaded polymethylmethacrylate bone cement. Cemex Genta System 80g holds the powder (80g) and liquid (29,3g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system. The device is supplied sterile, for single use.Cemex Genta System 80g is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. | MBB,LOD | Bone Cement, Antibiotic,Bone Cement | 2 | CEMEX GENTA SYSTEM 80G | |
26 | 28031497000507 | 1400/IG US | Cemex Genta HV is a high viscosity antibiotic-loaded polymethylmethacrylate bone Cemex Genta HV is a high viscosity antibiotic-loaded polymethylmethacrylate bone cement. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use.Cemex Genta HV is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. | LOD,MBB | Bone Cement,Bone Cement, Antibiotic | 2 | Cemex Genta HV | |
27 | 28031497000354 | 1510/S | Cemex System Fast 70g is a polymethylmethacrylate bone cement with a fast settin Cemex System Fast 70g is a polymethylmethacrylate bone cement with a fast setting. Cemex System Fast 70g holds the powder (70g) and liquid (29,3g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system.The device is supplied sterile, for single use.Cemex System Fast 70g is indicated for the fixation of joint prosthesis implants to the host bone. | LOD | Bone Cement | 2 | CEMEX SYSTEM FAST 70G | |
28 | 28031497000057 | 1200/S | Cemex XL is a low viscosity polymethylmethacrylate bone cement. It is composed b Cemex XL is a low viscosity polymethylmethacrylate bone cement. It is composed by two components (50g powder and 18.33g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use.Cemex XL is indicated for the fixation of joint prosthesis implants to the host bone. | LOD | Bone Cement | 2 | CEMEX XL | |
29 | 08031497002866 | SPC90Z3 | InterSpace Tapered Wedge Stem Trial is intended to be used for the selection of InterSpace Tapered Wedge Stem Trial is intended to be used for the selection of the right size of InterSpace Tapered Wedge Stem to be implanted. | HWT | Template | 1 | InterSpace Tapered Wedge Stem Trial | |
30 | 08031497002224 | ASA0050 | Revision Cannula is intended to be used to distal femoral bone cement delivery t Revision Cannula is intended to be used to distal femoral bone cement delivery through Tecres' Cemex System. | KDD | Kit, Surgical Instrument, Disposable | 1 | Revision Cannula | |
31 | 08031497002163 | 65.01.111US | MectaCem-X HV with Gentamicin is a low viscosity antibiotic-loaded polymethylme MectaCem-X HV with Gentamicin is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X HV with Gentamicin is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. | LOD,MBB | Bone Cement,Bone Cement, Antibiotic | 2 | MectaCem-X HV with Gentamicin | |
32 | 08031497000763 | ASB0080 | BONE INJECTION NEEDLE beveled tip 9 Gauge 150 mm length with metal handgrip inte BONE INJECTION NEEDLE beveled tip 9 Gauge 150 mm length with metal handgrip intended for the injection of acrylic resin. | KIH | Dispenser, Cement | 1 | BONE INJECTION NEEDLE beveled tip 9 Gauge 150 mm length | |
33 | 08031497000732 | ASB0000 | BONE INJECTION NEEDLE beveled tip 9 Gauge 150 mm length with plastic handgrip in BONE INJECTION NEEDLE beveled tip 9 Gauge 150 mm length with plastic handgrip intended for the injection of acrylic resin. | KIH | Dispenser, Cement | 1 | BONE INJECTION NEEDLE beveled tip 9 Gauge 150 mm length | |
34 | 28031497002006 | ASC0030 | Mendec Aqua Cartridge is intended to be used with Mendec Aqua in vertebral augme Mendec Aqua Cartridge is intended to be used with Mendec Aqua in vertebral augmentation procedure (vertebroplasty, kyphoplasty and screw-augmentation) when the acrylic resin/bone void filler loaded in a single cartridge is not sufficient to complete the surgical procedure. | OAR | Injector, Vertebroplasty (Does Not Contain Cement) | 1 | MENDEC AQUA CARTRIDGE | |
35 | 28031497000668 | SPC0522 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | MBB,KWL,KWY | Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal,Prosthesis, Hip, Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal,Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | InterSpace Hip | |
36 | 28031497000958 | 13A2111 US | Cemex Genta System Fast 40g is an antibiotic-loaded polymethylmethacrylate bone Cemex Genta System Fast 40g is an antibiotic-loaded polymethylmethacrylate bone cement. Cemex Genta System Fast 40g holds the powder (40g) and liquid (16,7g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system and has a fast setting. The device is supplied sterile, for single use.Cemex Genta System Fast 40g is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. | MBB,LOD | Bone Cement, Antibiotic,Bone Cement | 2 | CEMEX GENTA SYSTEM FAST 40G | |
37 | 28031497000651 | SPC0422 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | MBB,KWL,KWY | Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal,Prosthesis, Hip, Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal,Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | InterSpace Hip | |
38 | 28031497000644 | SPC0322 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | MBB,KWL,KWY | Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal,Prosthesis, Hip, Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal,Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | InterSpace Hip | |
39 | 28031497000521 | 13C2000 | Mendec Spine Kit is a device for the treatment of pathological fractures of the Mendec Spine Kit is a device for the treatment of pathological fractures of the vertebral body using a vertebroplasty procedure.The device is composed by an acrylic resin and a delivery system. | NDN | Cement, Bone, Vertebroplasty | 2 | Mendec Spine Kit | |
40 | 28031497000637 | SPC0222 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | MBB,KWL,KWY | Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal,Prosthesis, Hip, Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal,Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | InterSpace Hip | |
41 | 28031497000620 | SPC0122 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | MBB,KWL,KWY | Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal,Prosthesis, Hip, Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal,Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | InterSpace Hip | |
42 | 28031497000613 | SPC0022 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cementcoated onto a stainless steel reinforcing structure. The device is sterile and single-use.InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | MBB,KWL,KWY | Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal,Prosthesis, Hip, Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal,Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | InterSpace Hip | |
43 | 28031497000484 | 1310/SG US | Cemex Genta System 60g is an antibiotic-loaded polymethylmethacrylate bone cemen Cemex Genta System 60g is an antibiotic-loaded polymethylmethacrylate bone cement. Cemex Genta System 60g holds the powder (60g) and liquid (22g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system. The device is supplied sterile, for single use. Cemex Genta System 60g is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. | MBB,LOD | Bone Cement, Antibiotic,Bone Cement | 2 | CEMEX GENTA SYSTEM 60G | |
44 | 28031497000323 | KIT-01 | Cemex Prep kit is intended to be used for helping the surgeons during the fixati Cemex Prep kit is intended to be used for helping the surgeons during the fixation of artificial joint prostheses with the acrylic bone cement. The device contains a number of accessories useful during a prosthesis implantation surgery performed using the cementing technique. The components are packaged all together in a unique sterile package single-use. | JDK | Prosthesis, Hip, Cement Restrictor | 2 | Cemex Prep Kit | |
45 | 08031497002149 | 65.01.113US | MectaCem-X LV with Gentamicin is a low viscosity antibiotic-loaded polymethylmet MectaCem-X LV with Gentamicin is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X LV with Gentamicin is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. | LOD,MBB | Bone Cement,Bone Cement, Antibiotic | 2 | MectaCem-X LV with Gentamicin | |
46 | 08031497001562 | TPA-8 | Cement Restrictor designed to be inserted into the femoral medullary canal to li Cement Restrictor designed to be inserted into the femoral medullary canal to limit the flow of bone cement and to aid the cement pressurization during primary or revision hip arthroplasty surgery. It is a single-use and permanent, implantable, sterile device. | JDK | Prosthesis, Hip, Cement Restrictor | 2 | Cement Restrictor | |
47 | 08031497001418 | TPA-24 | Cement Restrictor designed to be inserted into the femoral medullary canal to li Cement Restrictor designed to be inserted into the femoral medullary canal to limit the flow of bone cement and to aid the cement pressurization during primary or revision hip arthroplasty surgery. It is a single-use and permanent, implantable, sterile device.Cement Restrictor is provided with the related inserter. | JDK | Prosthesis, Hip, Cement Restrictor | 2 | Cement Restrictor | |
48 | 08031497001401 | TPA-18 | Cement Restrictor designed to be inserted into the femoral medullary canal to li Cement Restrictor designed to be inserted into the femoral medullary canal to limit the flow of bone cement and to aid the cement pressurization during primary or revision hip arthroplasty surgery. It is a single-use and permanent, implantable, sterile device. Cement Restrictor is provided with the related inserter. | JDK | Prosthesis, Hip, Cement Restrictor | 2 | Cement Restrictor | |
49 | 08031497000695 | SPN0915 | BONE INJECTION NEEDLE diamond tip 9 Gauge 150 mm length with plastic handgrip in BONE INJECTION NEEDLE diamond tip 9 Gauge 150 mm length with plastic handgrip intended for the injection of acrylic resin. | KIH | Dispenser, Cement | 1 | BONE INJECTION NEEDLE diamond tip 9 Gauge 150 mm length | |
50 | 28031497000217 | 1500/S | Cemex System 80g is a polymethylmethacrylate bone cement. Cemex System 80g holds Cemex System 80g is a polymethylmethacrylate bone cement. Cemex System 80g holds the powder (80g) and liquid (29,3g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system.The device is supplied sterile, for single use.Cemex System 80g is indicated for the fixation of joint prosthesis implants to the host bone. | LOD | Bone Cement | 2 | CEMEX SYSTEM 80G |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00190446137993 | 600-10-100 | COBALT-G MV BONE CEMENT 40GM | DJO SURGICAL | ENCORE MEDICAL, L.P. | |
2 | B5780011191400115 | LV+G | 00-1119-140-01 | PALACOS® LV+G is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone PALACOS® LV+G is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. It contains the aminoglycoside antibiotic gentamicin.PALACOS® LV+G contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS® LV+G has been coloured with chlorophyll (E141).The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes. | PALACOS | HERAEUS MEDICAL GMBH |
3 | B578001113140011 | R+G | 00-1113-140-01 | PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone su PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, initially produces a liquid and then a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and Transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive serves as optical marking of the bone cement at the site of the operation. | PALACOS | HERAEUS MEDICAL GMBH |
4 | B278SB4044V03M0 | SB-4044V-03M | SB-4044V-03M | MODULAR REDUCED RESECTION COLLAR, 40MM X 44MM | ELEOS Limb Salvage System | ONKOS SURGICAL, INC. |
5 | B278SB3640V03M0 | SB-3640V-03M | SB-3640V-03M | MODULAR REDUCED RESECTION COLLAR, 36MM X 40MM | ELEOS Limb Salvage System | ONKOS SURGICAL, INC. |
6 | B278PB4000R03M0 | PB-4000R-03M | PB-4000R-03M | MODULAR POROUS BIOGRIP® COLLAR, 40MM, HA COATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
7 | B278PB3600R03M0 | PB-3600R-03M | PB-3600R-03M | MODULAR POROUS BIOGRIP® COLLAR, 36MM, HA COATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
8 | B278PB3200R03M0 | PB-3200R-03M | PB-3200R-03M | MODULAR POROUS BIOGRIP® COLLAR, 32MM, HA COATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
9 | B278PB2800R03M0 | PB-2800R-03M | PB-2800R-03M | MODULAR POROUS BIOGRIP® COLLAR, 28MM, HA COATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
10 | B278PB2400R03M0 | PB-2400R-03M | PB-2400R-03M | MODULAR POROUS BIOGRIP® COLLAR, 24MM, HA COATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
11 | B278HR3000103M0 | HR-30001-03M | HR-30001-03M | ELEOS MODULAR COLLAR LOCKING RING AND IMPACTOR TIP | ELEOS Limb Salvage System | ONKOS SURGICAL, INC. |
12 | B278HR3000003M0 | HR-30000-03M | HR-30000-03M | ELEOS MODULAR COLLAR LOCKING RING | ELEOS Limb Salvage System | ONKOS SURGICAL, INC. |
13 | B278HC1712003M0 | HC-17120-03M | HC-17120-03M | SEGMENTAL COLLAR STEM, CEMENTED, 17MM X 100MM | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
14 | B278HC1512003M0 | HC-15120-03M | HC-15120-03M | SEGMENTAL COLLAR STEM, CEMENTED, 15MM X 100MM | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
15 | B278HC1312003M0 | HC-13120-03M | HC-13120-03M | SEGMENTAL COLLAR STEM, CEMENTED, 13MM X 100MM | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
16 | B278HC1112003M0 | HC-11120-03M | HC-11120-03M | SEGMENTAL COLLAR STEM, CEMENTED, 11MM X 100MM | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
17 | B278HC1010003M0 | HC-10100-03M | HC-10100-03M | SEGMENTAL COLLAR STEM, CEMENTED, 10MM X 100MM | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
18 | B278HC0910003M0 | HC-09100-03M | HC-09100-03M | SEGMENTAL COLLAR STEM, CEMENTED, 9MM X 100MM | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
19 | B278HB4000R03M0 | HB-4000R-03M | HB-4000R-03M | MODULAR POROUS BIOGRIP® COLLAR, 40MM, UNCOATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
20 | B278HB3600R03M0 | HB-3600R-03M | HB-3600R-03M | MODULAR POROUS BIOGRIP® COLLAR, 36MM, UNCOATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
21 | B278HB3200R03M0 | HB-3200R-03M | HB-3200R-03M | MODULAR POROUS BIOGRIP® COLLAR, 32MM, UNCOATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
22 | B278HB2800R03M0 | HB-2800R-03M | HB-2800R-03M | MODULAR POROUS BIOGRIP® COLLAR, 28MM, UNCOATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
23 | B278HB2400R03M0 | HB-2400R-03M | HB-2400R-03M | MODULAR POROUS BIOGRIP® COLLAR, 24MM, UNCOATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
24 | 28031497000958 | 13A2111 US | Cemex Genta System Fast 40g is an antibiotic-loaded polymethylmethacrylate bone Cemex Genta System Fast 40g is an antibiotic-loaded polymethylmethacrylate bone cement. Cemex Genta System Fast 40g holds the powder (40g) and liquid (16,7g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system and has a fast setting. The device is supplied sterile, for single use.Cemex Genta System Fast 40g is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. | CEMEX GENTA SYSTEM FAST 40G | TECRES SPA | |
25 | 28031497000668 | SPC0522 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
26 | 28031497000668 | SPC0522 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
27 | 28031497000668 | SPC0522 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
28 | 28031497000651 | SPC0422 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
29 | 28031497000651 | SPC0422 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
30 | 28031497000651 | SPC0422 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
31 | 28031497000644 | SPC0322 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
32 | 28031497000644 | SPC0322 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
33 | 28031497000644 | SPC0322 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
34 | 28031497000637 | SPC0222 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
35 | 28031497000637 | SPC0222 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
36 | 28031497000637 | SPC0222 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
37 | 28031497000620 | SPC0122 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
38 | 28031497000620 | SPC0122 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
39 | 28031497000620 | SPC0122 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
40 | 28031497000613 | SPC0022 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cementcoated onto a stainless steel reinforcing structure. The device is sterile and single-use.InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
41 | 28031497000613 | SPC0022 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cementcoated onto a stainless steel reinforcing structure. The device is sterile and single-use.InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
42 | 28031497000613 | SPC0022 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cementcoated onto a stainless steel reinforcing structure. The device is sterile and single-use.InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
43 | 28031497000606 | SPK0222 | Temporary knee spacer with gentamicin. InterSpace Knee is composed of fully form Temporary knee spacer with gentamicin. InterSpace Knee is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement.The device is sterile and single-use.InterSpace Knee is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. InterSpace Knee is applied on the femoral condyles and on the tibial plate following removal of the existing implantand radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Knee is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Knee | TECRES SPA | |
44 | 28031497000590 | SPK0122 | Temporary knee spacer with gentamicin. InterSpace Knee is composed of fully form Temporary knee spacer with gentamicin. InterSpace Knee is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement.The device is sterile and single-use.InterSpace Knee is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. InterSpace Knee is applied on the femoral condyles and on the tibial plate following removal of the existing implantand radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Knee is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Knee | TECRES SPA | |
45 | 28031497000583 | SPK0022 | Temporary knee spacer with gentamicin. InterSpace Knee is composed of fully form Temporary knee spacer with gentamicin. InterSpace Knee is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement.The device is sterile and single-use.InterSpace Knee is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. InterSpace Knee is applied on the femoral condyles and on the tibial plate following removal of the existing implantand radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Knee is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Knee | TECRES SPA | |
46 | 28031497000538 | 13A2101 US | Cemex Genta System Fast 70g is an antibiotic-loaded polymethylmethacrylate bone Cemex Genta System Fast 70g is an antibiotic-loaded polymethylmethacrylate bone cement. Cemex Genta System Fast 70g holds the powder (70g) and liquid (29,3g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system. The device is supplied sterile, for single use. Cemex Genta System Fast 70g is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. | CEMEX GENTA SYSTEM FAST 70G | TECRES SPA | |
47 | 28031497000514 | 1500/SG US | Cemex Genta System 80g is an antibiotic-loaded polymethylmethacrylate bone cemen Cemex Genta System 80g is an antibiotic-loaded polymethylmethacrylate bone cement. Cemex Genta System 80g holds the powder (80g) and liquid (29,3g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system. The device is supplied sterile, for single use.Cemex Genta System 80g is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. | CEMEX GENTA SYSTEM 80G | TECRES SPA | |
48 | 28031497000507 | 1400/IG US | Cemex Genta HV is a high viscosity antibiotic-loaded polymethylmethacrylate bone Cemex Genta HV is a high viscosity antibiotic-loaded polymethylmethacrylate bone cement. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use.Cemex Genta HV is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. | Cemex Genta HV | TECRES SPA | |
49 | 28031497000491 | 1400/AG US | Cemex Genta LV is a low viscosity antibiotic-loaded polymethylmethacrylate bone Cemex Genta LV is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use.Cemex Genta LV is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. | Cemex Genta LV | TECRES SPA | |
50 | 28031497000484 | 1310/SG US | Cemex Genta System 60g is an antibiotic-loaded polymethylmethacrylate bone cemen Cemex Genta System 60g is an antibiotic-loaded polymethylmethacrylate bone cement. Cemex Genta System 60g holds the powder (60g) and liquid (22g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system. The device is supplied sterile, for single use. Cemex Genta System 60g is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. | CEMEX GENTA SYSTEM 60G | TECRES SPA |