No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05056139232107 | 1125187 | Tibial Insert CS Fixed #5 Th16 | JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | Unity Total Knee System | |
2 | 05056139220777 | MDI345 | MDI345 | Patellar clamp | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | HLS KneeTec |
3 | 05056139214806 | MDE006 | MDE006 | Tibial cutting block | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | HLS Noetos |
4 | 05055343899410 | 9210129 | 9210129 | Trinity Introducer Handle | LZO,LWJ,MEH | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented,Prosthesis, hip, semi-constrained, metal/polymer, uncemented,Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate | 2 | Trinity Acetabular Hip System |
5 | 05055343897454 | 6959670 | 6959670 | Curved Broach Handle | LZO,JDI | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented,Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | Corin Metafix Hip Stem |
6 | 05055343891667 | 340.440H | Size 10 Femoral Broach | MEH,OQI,JDI,KWY,KWL,LZO | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicu Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate,Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented,Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented,Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented,Prosthesis, Hip, Hemi-, Femoral, Metal,Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | Metafix Hip Stem | |
7 | 05055343884539 | 123.355.06 | 123.355.06 | Tibial Templates / Trials - Size 6 | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | Unity Total Knee System |
8 | 05055343884249 | 695.1110 | 695.1110 | RASP SIZE 11 | MEH,KWY,KWL,LZO | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicu Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate,Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented,Prosthesis, hip, hemi-, femoral, metal,Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 2 | TriFit TS Blade Stem |
9 | 05055343880012 | 580.9063 | 580.9063 | Starter Awl | LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 2 | MiniHip Stem |
10 | 05055343867464 | 340.363 | 340.363 | Anterior Stem Impactor | JDI,LZO | Prosthesis, hip, semi-constrained, metal/polymer, cemented,Prosthesis, hip, semi Prosthesis, hip, semi-constrained, metal/polymer, cemented,Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 2 | Corin Metafix Hip Stem |
11 | 05055343839768 | 576-05-246 | 576-05-246 | UNIPOLAR MOD HEADS | KWL | Prosthesis, hip, hemi-, femoral, metal | 2 | Corin Unipolar Modular Head |
12 | 05055196919457 | 479.248B | 479.248B | NXT | Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing | 3 | Cormet | |
13 | 05055196970496 | 921.108 | 921.108 | DRILL GUIDE | MEH,LZO,LWJ | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicu Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate,Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented,Prosthesis, hip, semi-constrained, metal/polymer, uncemented | 2 | Trinity Acetabular Hip System |
14 | 05055196934351 | 124.316P | 124.316P | CFIT STEM | JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 2 | C-Fit Femoral Hip System |
15 | 05055196934344 | 124.315P | 124.315P | CFIT STEM | JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 2 | C-Fit Femoral Hip System |
16 | 05055196949669 | 580.9410 | 580.9410 | Stem Extractor | LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 2 | MiniHip Stem |
17 | 05055196940604 | 11903 | 11903 | ALLEN KEY | JDG | Prosthesis, hip, femoral component, cemented, metal | 2 | Corin Taper-Fit Total Hip System |
18 | 05055196927490 | 321.04.356 | 321.04.356 | Trinity Acetabular Shell Ø56mm Taper Size 4 | LWJ,MEH,LZO | Prosthesis, hip, semi-constrained, metal/polymer, uncemented,Prosthesis, hip, se Prosthesis, hip, semi-constrained, metal/polymer, uncemented,Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate,Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 2 | Trinity Acetabular Hip System |
19 | 05055196926943 | 921.103 | 921.103 | FLEXIBLE DRIVE | MEH,LWJ,LZO | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicu Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate,Prosthesis, hip, semi-constrained, metal/polymer, uncemented,Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 2 | Trinity Acetabular Hip System |
20 | 05055196921313 | 118.360 | 118.360 | BONE SCREW | JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 2 | C-Fit & DC-Fit Acetabular Cup System |
21 | 05055196919495 | 479.256B | 479.256B | Cormet acetabular cup - 56mm size 7 Bi-coated | NXT | Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing | 3 | Cormet |
22 | 05055196909014 | BC8K-1G01-012 | BC8K-1G01-012 | TIBIAL ALIGNMENT JIG | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Uniglide Unicondylar Knee Prosthesis |
23 | 05055196908345 | 616.0060 | 616.0060 | FEMORAL SLOT PUNCH | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Uniglide Unicondylar Knee Prosthesis |
24 | 08033466014481 | 120375024 | Distal Component 200mm Length; 24mm Diameter | MEH,LZO | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calc Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate,Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | Revival Modular Hip Stem | |
25 | 08033466014405 | 120374024 | Distal Component 160mm Length; 24mm Diameter | MEH,LZO | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calc Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate,Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | Revival Modular Hip Stem | |
26 | 08033466132154 | 120376021 | Distal Component 240mm Length; 21mm Diameter | MEH,LZO | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calc Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate,Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | Revival Modular Hip Stem | |
27 | 08033466132147 | 120376015 | Distal Component 240mm Length; 15mm Diameter | MEH,LZO | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calc Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate,Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | Revival Modular Hip Stem | |
28 | 08033466132130 | 120375021 | Distal Component 200mm Length; 21mm Diameter | MEH,LZO | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calc Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate,Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | Revival Modular Hip Stem | |
29 | 08033466132123 | 120374021 | Distal Component 160mm Length; 21mm Diameter | MEH,LZO | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calc Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate,Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | Revival Modular Hip Stem | |
30 | 08033466109446 | 120373921 | Distal Component 100mm Length; 21mm Diameter | MEH,LZO | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calc Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate,Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | Revival Modular Hip Stem | |
31 | 08033466109439 | 120373919 | Distal Component 100mm Length; 19mm Diameter | MEH,LZO | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calc Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate,Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | Revival Modular Hip Stem | |
32 | 08033466109422 | 120373917 | Distal Component 100mm Length; 17mm Diameter | MEH,LZO | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calc Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate,Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | Revival Modular Hip Stem | |
33 | 08033466101310 | 120373915 | Distal Component 100mm Length; 15mm Diameter | MEH,LZO | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calc Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate,Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | Revival Modular Hip Stem | |
34 | 08033466088161 | 120375015 | Distal Component 200mm Length; 15mm Diameter | MEH,LZO | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calc Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate,Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | Revival Modular Hip Stem | |
35 | 08033466088154 | 120374015 | Distal Component 160mm Length; 15mm Diameter | MEH,LZO | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calc Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate,Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | Revival Modular Hip Stem | |
36 | 08033466014566 | 120376024 | Distal Component 240mm Length; 24mm Diameter | MEH,LZO | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calc Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate,Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | Revival Modular Hip Stem | |
37 | 05056139219856 | MDI193 | MDI193 | Cloche ream Ø45 | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | HLS KneeTec |
38 | 05056139219849 | MDI192 | MDI192 | Cloche ream Ø40 | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | HLS KneeTec |
39 | 05056139219832 | MDI191 | MDI191 | Cloche ream Ø34 | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | HLS KneeTec |
40 | 05056139219825 | MDI185 | MDI185 | Reaming guide Ø50 | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | HLS KneeTec |
41 | 05056139219818 | MDI184 | MDI184 | Reaming guide Ø47 | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | HLS KneeTec |
42 | 05056139219801 | MDI183 | MDI183 | Reaming guide Ø45 | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | HLS KneeTec |
43 | 05056139219795 | MDI182 | MDI182 | Reaming guide Ø40 | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | HLS KneeTec |
44 | 05056139219788 | MDI181 | MDI181 | Reaming guide Ø34 | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | HLS KneeTec |
45 | 05056139219771 | MDI176 | MDI176 | Reaming stop | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | HLS KneeTec |
46 | 05056139220401 | MDI300 | MDI300 | Resection Check | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | HLS KneeTec |
47 | 05056139219863 | MDI194 | MDI194 | Cloche ream Ø47 | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | HLS KneeTec |
48 | 05056139233661 | MVV062 | MVV062 | Pin extractor | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | HLS Uni Evolution |
49 | 05056139234088 | 2110061 | 2110061 | Acetabular Trial Ø61 | KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | Corin BiPolar-i |
50 | 05056139234002 | 2110054 | 2110054 | Acetabular Trial Ø54 | KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | Corin BiPolar-i |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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 | |
2 | 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 | |
3 | 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 | |
4 | 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 | |
5 | 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 | |
6 | 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 | |
7 | 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 | |
8 | 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 | |
9 | 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 | |
10 | 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 | |
11 | 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 | |
12 | 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 | |
13 | 17613327311089 | I-H1236HA00 | I-H1236HA00 | SPECIALTY TRIDENT TRIAL CONTAINMENT SCREW-LONGER | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
14 | 17613327311089 | I-H1236HA00 | I-H1236HA00 | SPECIALTY TRIDENT TRIAL CONTAINMENT SCREW-LONGER | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
15 | 17613327311089 | I-H1236HA00 | I-H1236HA00 | SPECIALTY TRIDENT TRIAL CONTAINMENT SCREW-LONGER | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
16 | 17613327311089 | I-H1236HA00 | I-H1236HA00 | SPECIALTY TRIDENT TRIAL CONTAINMENT SCREW-LONGER | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
17 | 17613327311089 | I-H1236HA00 | I-H1236HA00 | SPECIALTY TRIDENT TRIAL CONTAINMENT SCREW-LONGER | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
18 | 17613327261100 | 0937-8-205 | 0937-8-205 | EXETER MIS HALF MOON FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
19 | 17613327261100 | 0937-8-205 | 0937-8-205 | EXETER MIS HALF MOON FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
20 | 17613327261100 | 0937-8-205 | 0937-8-205 | EXETER MIS HALF MOON FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
21 | 17613327261100 | 0937-8-205 | 0937-8-205 | EXETER MIS HALF MOON FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
22 | 17613327261100 | 0937-8-205 | 0937-8-205 | EXETER MIS HALF MOON FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
23 | 17613327141358 | 0937-3-215 | 0937-3-215 | EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
24 | 17613327141358 | 0937-3-215 | 0937-3-215 | EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
25 | 17613327141358 | 0937-3-215 | 0937-3-215 | EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
26 | 17613327141358 | 0937-3-215 | 0937-3-215 | EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
27 | 17613327141358 | 0937-3-215 | 0937-3-215 | EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
28 | 17613327141310 | 0937-3-225 | 0937-3-225 | EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
29 | 17613327141310 | 0937-3-225 | 0937-3-225 | EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
30 | 17613327141310 | 0937-3-225 | 0937-3-225 | EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
31 | 17613327141310 | 0937-3-225 | 0937-3-225 | EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
32 | 17613327141310 | 0937-3-225 | 0937-3-225 | EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
33 | M716AS7WC0 | AS-7WC | AS-7WC | Distal centalizer, Size Wide, PMMA | OrthoMedFlex | ORTHOMEDFLEX LLC |
34 | M716AS725P0 | AS-725P | AS-725P | Cement Plug, Size 25mm, LLDPE | OrthoMedFlex | ORTHOMEDFLEX LLC |
35 | M716AS724P0 | AS-7-24P | AS-7-24P | Cement Plug, 24mm | OrthoMedFlex, LLC | ORTHOMEDFLEX LLC |
36 | M716AS721P0 | AS-721P | AS-721P | Cement Plug, Size 21mm, LLDPE | OrthoMedFlex | ORTHOMEDFLEX LLC |
37 | M716AS7200 | AS-720 | AS-720 | Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 20, Ti6AI Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 20, Ti6AI4V Alloy with HA Coating | OrthoMedFlex | ORTHOMEDFLEX LLC |
38 | M716AS718P0 | AS-7-18P | AS-7-18P | Cement Plug, 18mm | OrthoMedFlex, LLC | ORTHOMEDFLEX LLC |
39 | M716AS7180 | AS-718 | AS-718 | Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 18, Ti6AI Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 18, Ti6AI4V Alloy with HA Coating | OrthoMedFlex | ORTHOMEDFLEX LLC |
40 | M716AS717P0 | AS-717P | AS-717P | Cement Plug, Size 17mm, LLDPE | OrthoMedFlex | ORTHOMEDFLEX LLC |
41 | M716AS7160 | AS-716 | AS-716 | Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 16, Ti6AI Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 16, Ti6AI4V Alloy with HA Coating | OrthoMedFlex | ORTHOMEDFLEX LLC |
42 | M716AS7150 | AS-715 | AS-715 | Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 15, Ti6AI Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 15, Ti6AI4V Alloy with HA Coating | OrthoMedFlex | ORTHOMEDFLEX LLC |
43 | M716AS7140 | AS-714 | AS-714 | Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 14, Ti6AI Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 14, Ti6AI4V Alloy with HA Coating | OrthoMedFlex | ORTHOMEDFLEX LLC |
44 | M716AS7130 | AS-713 | AS-713 | Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 13, Ti6AI Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 13, Ti6AI4V Alloy with HA Coating | OrthoMedFlex | ORTHOMEDFLEX LLC |
45 | M716AS712P0 | AS7-12P | AS7-12P | Cement Plug, 12mm | OrthoMedFlex, LLC | ORTHOMEDFLEX LLC |
46 | M716AS7120 | AS-712 | AS-712 | Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 12, Ti6AI Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 12, Ti6AI4V Alloy with HA Coating | OrthoMedFlex | ORTHOMEDFLEX LLC |
47 | M716AS7110 | AS-711 | AS-711 | Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 11, Ti6AI Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 11, Ti6AI4V Alloy with HA Coating | OrthoMedFlex | ORTHOMEDFLEX LLC |
48 | M716AS7100 | AS-710 | AS-710 | Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 10, Ti6AI Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 10, Ti6AI4V Alloy with HA Coating | OrthoMedFlex | ORTHOMEDFLEX LLC |
49 | M716AS7090 | AS-709 | AS-709 | Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 9, Ti6AI4 Kratos Hip Stem, Lateralized High Offset Collarless, Cementless - Size 9, Ti6AI4V Alloy with HA Coating | OrthoMedFlex | ORTHOMEDFLEX LLC |
50 | M716AS6200 | AS-620 | AS-620 | Kratos Hip Stem, Standard Offset Collarless, Cementless - Size 20, Ti6AI4V Alloy Kratos Hip Stem, Standard Offset Collarless, Cementless - Size 20, Ti6AI4V Alloy with HA Coating | OrthoMedFlex | ORTHOMEDFLEX LLC |