| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 08058964726087 | 900001 144818 | "Disposable cement spacer molds with metal reinforcement stem are indicated for "Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge." | MBB,KWS | Bone Cement, Antibiotic,Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | SpaceFlex Shoulder | |
| 2 | 08058964726070 | 900001 124818 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | MBB,KWS | Bone Cement, Antibiotic,Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | SpaceFlex Shoulder | |
| 3 | 08058964726063 | 900001 124215 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | MBB,KWS | Bone Cement, Antibiotic,Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | SpaceFlex Shoulder | |
| 4 | 08058964726056 | 900001 104818 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | MBB,KWS | Bone Cement, Antibiotic,Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | SpaceFlex Shoulder | |
| 5 | 08058964726049 | 900001 104215 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | MBB,KWS | Bone Cement, Antibiotic,Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | SpaceFlex Shoulder | |
| 6 | 08058964724977 | 900001 084215 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | MBB,KWS | Bone Cement, Antibiotic,Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | SpaceFlex Shoulder | |
| 7 | 08058964726766 | 900027 | 900027 | Kyphoplasty Balloon Catheter | NDN,HRX | Cement, Bone, Vertebroplasty,Arthroscope | 2 | Winch Kyphoplasty ( 15 mm) 11 Gauge Balloon Catheter |
| 8 | 08058964726759 | 800019 | 800019 | Bone Cement | MBB,LOD | Bone Cement, Antibiotic,Bone Cement | 2 | OrthoSteady G |
| 9 | 08058964726339 | 900027 | 900027 | Kyphoplasty Balloon Catheter | HRX,NDN | Arthroscope,Cement, Bone, Vertebroplasty | 2 | Winch Kyphoplasty ( 15 mm) 11 Gauge Balloon Catheter |
| 10 | 08058964726773 | 900028 | 900028 | Kyphoplasty Balloon Catheter | HRX,NDN | Arthroscope,Cement, Bone, Vertebroplasty | 2 | Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter |
| 11 | 08058964726407 | 900028 | 900028 | Kyphoplasty Balloon Catheter | NDN,HRX | Cement, Bone, Vertebroplasty,Arthroscope | 2 | Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter |
| 12 | 08058964726186 | 900008 | SpaceFlex Hip Instrument Kit is intended to be used in combination with SpaceFle SpaceFlex Hip Instrument Kit is intended to be used in combination with SpaceFlex Hip to mold temporary prosthesis. | MBB,KWY,KWL | Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented,Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | SpaceFlex Hip Instrument Kit | |
| 13 | 08058964726902 | 900005 15 | Disposable custom modular spacer mold | KWL,KWY,MBB | Prosthesis, Hip, Hemi-, Femoral, Metal,Prosthesis, Hip, Hemi-, Femoral, Metal/Po Prosthesis, Hip, Hemi-, Femoral, Metal,Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented,Bone Cement, Antibiotic | 2 | SpaceFlex Hip | |
| 14 | 08058964726896 | 900005 13 | Disposable custom modular spacer mold | MBB,KWY,KWL | Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented,Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | SpaceFlex Hip | |
| 15 | 08058964726889 | 900005 10 | Disposable custom modular spacer mold | KWL,KWY,MBB | Prosthesis, Hip, Hemi-, Femoral, Metal,Prosthesis, Hip, Hemi-, Femoral, Metal/Po Prosthesis, Hip, Hemi-, Femoral, Metal,Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented,Bone Cement, Antibiotic | 2 | SpaceFlex Hip | |
| 16 | 08058964727039 | 900189 80 | Orthopedic bone cement modular spacer for temporary knee prosthesis | MBB,JWH | Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | SpaceFlex Knee | |
| 17 | 08058964726940 | 900189 70 | MBB,JWH | Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | SpaceFlex Knee | ||
| 18 | 08058964726933 | 900189 60 | MBB,JWH | Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | SpaceFlex Knee | ||
| 19 | 08058964723970 | 800002 | Radiopaque Bone Cement | LOD | Bone Cement | 2 | G1 40 Radiopaque Bone Cement | |
| 20 | 08058964726742 | 900187 | 900187 | Curette with curved distal end used to create a cavity inside the vertebra. | HTF | Curette | 1 | FLEX DRILL 13G |
| 21 | 08058964723819 | 800039 | 800039 | Radiopaque Bone Cement for vertebral consolidation | NDN,LOD | Cement, Bone, Vertebroplasty,Bone Cement | 2 | V-STEADY |
| 22 | 08058964720245 | 800036 | 800036 | Radiopaque Bone Cement for vertebral consolidation | LOD,NDN | Bone Cement,Cement, Bone, Vertebroplasty | 2 | V-FAST |
| 23 | 08058964720047 | 800004 | Radiopaque Bone Cement | LOD | Bone Cement | 2 | G3 40 Radiopaque Bone Cement |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 10886982262257 | 07.702.040S | 07702040S | TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT - STERILE | TRAUMACEM | SYNTHES GMBH |
| 2 | 10885380066528 | CMT-40-1G | CMT-40-1G | Orthopaedic cement, medicated | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 3 | 10885380066528 | CMT-40-1G | CMT-40-1G | Orthopaedic cement, medicated | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 4 | 10885380066511 | CMT-40-1 | CMT-40-1 | Orthopaedic cement, non-medicated | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 5 | 10603295174295 | 5450-50-501 | 545050501 | Smartset GMV HIGH PERFORMANCE GENTAMICIN Medium Viscosity Bone Cement 40g | SMARTSET | DEPUY (IRELAND) |
| 6 | 10603295174295 | 5450-50-501 | 545050501 | Smartset GMV HIGH PERFORMANCE GENTAMICIN Medium Viscosity Bone Cement 40g | SMARTSET | DEPUY (IRELAND) |
| 7 | 10603295174288 | 5450-35-500 | 545035500 | Smartset GHV GENTAMICIN High Viscosity Bone Cement 40g | SMARTSET | DEPUY (IRELAND) |
| 8 | 10603295174288 | 5450-35-500 | 545035500 | Smartset GHV GENTAMICIN High Viscosity Bone Cement 40g | SMARTSET | DEPUY (IRELAND) |
| 9 | 10603295174271 | 5450-32-500 | 545032500 | DEPUY CMW 2 GENTAMICIN Fast Set Bone Cement 20g | NA | DEPUY (IRELAND) |
| 10 | 10603295174271 | 5450-32-500 | 545032500 | DEPUY CMW 2 GENTAMICIN Fast Set Bone Cement 20g | NA | DEPUY (IRELAND) |
| 11 | 10603295174264 | 5450-31-500 | 545031500 | DEPUY CMW 1 GENTAMICIN Bone Cement 40g | NA | DEPUY (IRELAND) |
| 12 | 10603295174264 | 5450-31-500 | 545031500 | DEPUY CMW 1 GENTAMICIN Bone Cement 40g | NA | DEPUY (IRELAND) |
| 13 | 10603295168638 | 3332-040 | 3332040 | DEPUY CMW 3 Medium Viscosity Bone Cement 40g | NA | DEPUY (IRELAND) |
| 14 | 10603295168621 | 3322-020 | 3322020 | DEPUY CMW 2 Fast Set Bone Cement 20g | NA | DEPUY (IRELAND) |
| 15 | 10603295168614 | 3312-040 | 3312040 | DEPUY CMW 1 High Viscosity Bone Cement 40g | NA | DEPUY (IRELAND) |
| 16 | 10603295168379 | 3122-040 | 3122040 | SmartSet HIGH PERFORMANCE MV Medium Viscosity Bone Cement 40g | SMARTSET | DEPUY (IRELAND) |
| 17 | 10603295168362 | 3122-020 | 3122020 | SmartSet HIGH PERFORMANCE MV Medium Viscosity Bone Cement 20g | SMARTSET | DEPUY (IRELAND) |
| 18 | 10603295168355 | 3102-080 | 3102080 | SmartSet ENDURANCE MV Medium Viscosity Bone Cement 80g | SMARTSET | DEPUY (IRELAND) |
| 19 | 10603295168355 | 3102-080 | 3102080 | SmartSet ENDURANCE MV Medium Viscosity Bone Cement 80g | SMARTSET | DEPUY (IRELAND) |
| 20 | 10603295168331 | 3092-040 | 3092040 | SmartSet HV High Viscosity Bone Cement 40g | SMARTSET | DEPUY (IRELAND) |
| 21 | 10603295168331 | 3092-040 | 3092040 | SmartSet HV High Viscosity Bone Cement 40g | SMARTSET | DEPUY (IRELAND) |
| 22 | 10603295168324 | 3092-020 | 3092020 | SmartSet HV High Viscosity Bone Cement 20g | SMARTSET | DEPUY (IRELAND) |
| 23 | 10603295168324 | 3092-020 | 3092020 | SmartSet HV High Viscosity Bone Cement 20g | SMARTSET | DEPUY (IRELAND) |
| 24 | M684141030001 | 14103000 | 14103000 | ORTHOSET® III BONE CEMENT | ORTHOSET® | MICROPORT ORTHOPEDICS INC. |
| 25 | M684141020001 | 14102000 | 14102000 | ORTHOSET® II BONE CEMENT | ORTHOSET® | MICROPORT ORTHOPEDICS INC. |
| 26 | M684141010001 | 14101000 | 14101000 | ORTHOSET® I BONE CEMENT | ORTHOSET® | MICROPORT ORTHOPEDICS INC. |
| 27 | 08058964727039 | 900189 80 | Orthopedic bone cement modular spacer for temporary knee prosthesis | SpaceFlex Knee | G21 SRL | |
| 28 | 08058964726940 | 900189 70 | SpaceFlex Knee | G21 SRL | ||
| 29 | 08058964726933 | 900189 60 | SpaceFlex Knee | G21 SRL | ||
| 30 | 08058964726902 | 900005 15 | Disposable custom modular spacer mold | SpaceFlex Hip | G21 SRL | |
| 31 | 08058964726896 | 900005 13 | Disposable custom modular spacer mold | SpaceFlex Hip | G21 SRL | |
| 32 | 08058964726889 | 900005 10 | Disposable custom modular spacer mold | SpaceFlex Hip | G21 SRL | |
| 33 | 08058964726759 | 800019 | 800019 | Bone Cement | OrthoSteady G | G21 SRL |
| 34 | 08058964726759 | 800019 | 800019 | Bone Cement | OrthoSteady G | G21 SRL |
| 35 | 08058964726186 | 900008 | SpaceFlex Hip Instrument Kit is intended to be used in combination with SpaceFle SpaceFlex Hip Instrument Kit is intended to be used in combination with SpaceFlex Hip to mold temporary prosthesis. | SpaceFlex Hip Instrument Kit | G21 SRL | |
| 36 | 08058964726087 | 900001 144818 | "Disposable cement spacer molds with metal reinforcement stem are indicated for "Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge." | SpaceFlex Shoulder | G21 SRL | |
| 37 | 08058964726070 | 900001 124818 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
| 38 | 08058964726063 | 900001 124215 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
| 39 | 08058964726056 | 900001 104818 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
| 40 | 08058964726049 | 900001 104215 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
| 41 | 08058964724977 | 900001 084215 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
| 42 | 08058964723970 | 800002 | Radiopaque Bone Cement | G1 40 Radiopaque Bone Cement | G21 SRL | |
| 43 | 08058964723819 | 800039 | 800039 | Radiopaque Bone Cement for vertebral consolidation | V-STEADY | G21 SRL |
| 44 | 08058964720245 | 800036 | 800036 | Radiopaque Bone Cement for vertebral consolidation | V-FAST | G21 SRL |
| 45 | 08058964720122 | 800009 | G3A 40 Bone Cement | G21 SRL | ||
| 46 | 08058964720122 | 800009 | G3A 40 Bone Cement | G21 SRL | ||
| 47 | 08058964720047 | 800004 | Radiopaque Bone Cement | G3 40 Radiopaque Bone Cement | G21 SRL | |
| 48 | 08031497002316 | KITCEMENT-US | Mendec Spine HV is a highly viscous, radio-opaque acrylic resin (PMMA based) for Mendec Spine HV is a highly viscous, radio-opaque acrylic resin (PMMA based) for vertebral augmentation procedures available as a closed mixing unit (the powder and liquid components are enclosed in a syringe-like device). | CEMENT KIT | TECRES SPA | |
| 49 | 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. | MectaCem-X HV with Gentamicin | TECRES SPA | |
| 50 | 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. | MectaCem-X HV with Gentamicin | TECRES SPA |