No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00855195006609 | GVLSLG | REMEDY SPECTRUM GV Femoral Long Stem LG | KWY,MBB,KWL | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented,Bone Ceme Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented,Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | Remedy Spectrum GV Spacer | |
2 | 00855195006593 | GVLSMD | REMEDY SPECTRUM GV Femoral Long Stem MD | KWL,MBB,KWY | Prosthesis, Hip, Hemi-, Femoral, Metal,Bone Cement, Antibiotic,Prosthesis, Hip, Prosthesis, Hip, Hemi-, Femoral, Metal,Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | Remedy Spectrum GV Spacer | |
3 | 00855195006586 | GVLSSM | REMEDY SPECTRUM GV Femoral Long Stem SM | KWY,MBB,KWL | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented,Bone Ceme Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented,Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | Remedy Spectrum GV Spacer | |
4 | 00855195006579 | GVSTLG | REMEDY SPECTRUM GV Femoral Stem LG | KWL,MBB,KWY | Prosthesis, Hip, Hemi-, Femoral, Metal,Bone Cement, Antibiotic,Prosthesis, Hip, Prosthesis, Hip, Hemi-, Femoral, Metal,Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | Remedy Spectrum GV Spacer | |
5 | 00855195006562 | GVSTMD | REMEDY SPECTRUM GV Femoral Stem MD | KWY,MBB,KWL | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented,Bone Ceme Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented,Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | Remedy Spectrum GV Spacer | |
6 | 00855195006555 | GVSTSM | REMEDY SPECTRUM GV Femoral Stem SM | KWL,MBB,KWY | Prosthesis, Hip, Hemi-, Femoral, Metal,Bone Cement, Antibiotic,Prosthesis, Hip, Prosthesis, Hip, Hemi-, Femoral, Metal,Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | Remedy Spectrum GV Spacer | |
7 | 00855195006548 | GVHDLG | REMEDY SPECTRUM GV Femoral Head - 60mm | KWY,MBB,KWL | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented,Bone Ceme Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented,Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | Remedy Spectrum GV Spacer | |
8 | 00855195006531 | GVHDMD | REMEDY SPECTRUM GV Femoral Head - 54mm | KWL,MBB,KWY | Prosthesis, Hip, Hemi-, Femoral, Metal,Bone Cement, Antibiotic,Prosthesis, Hip, Prosthesis, Hip, Hemi-, Femoral, Metal,Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | Remedy Spectrum GV Spacer | |
9 | 00855195006524 | GVHDSM | REMEDY SPECTRUM GV Femoral Head - 46mm | KWY,MBB,KWL | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented,Bone Ceme Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented,Bone Cement, Antibiotic,Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | Remedy Spectrum GV Spacer | |
10 | 00855195006241 | UNITE40 | Unite AB Bone Cement | LOD | Bone Cement | 2 | Unite Cement | |
11 | 00850011453063 | GVHDXS | GVHDXS | REMEDY SPECTRUM® GV Femoral Head - 40mm | KWL,KWY | 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 | 2 | Remedy Spectrum GV Spacer |
12 | 00855195006708 | RSK175 | REMEDY® Stem Extension Component 175 | JWH,MBB | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer,Bone Cement, Antibiotic | 2 | Remedy Spacer | |
13 | 00855195006692 | RSK100 | REMEDY® Stem Extension Component 100 | MBB,JWH | Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | Remedy Spacer | |
14 | 00855195006685 | RSKTLG | REMEDY® Stemmed Tibial Component LG | JWH,MBB | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer,Bone Cement, Antibiotic | 2 | Remedy Spacer | |
15 | 00855195006678 | RSKTMD | REMEDY® Stemmed Tibial Component MD | MBB,JWH | Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | Remedy Spacer | |
16 | 00855195006661 | RSKTSM | REMEDY® Stemmed Tibial Component SM | JWH,MBB | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer,Bone Cement, Antibiotic | 2 | Remedy Spacer | |
17 | 00855195006654 | RSKFXL | REMEDY® Stemmed Femoral Component XL | MBB,JWH | Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | Remedy Spacer | |
18 | 00855195006647 | RSKFLG | REMEDY® Stemmed Femoral Component LG | JWH,MBB | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer,Bone Cement, Antibiotic | 2 | Remedy Spacer | |
19 | 00855195006630 | RSKFMD | REMEDY® Stemmed Femoral Component MD | MBB,JWH | Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | Remedy Spacer | |
20 | 00855195006623 | RSKFSM | REMEDY® Stemmed Femoral Component SM | JWH,MBB | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer,Bone Cement, Antibiotic | 2 | Remedy Spacer | |
21 | 00855195006357 | RKTBMD | Remedy Tibial Component 70mm | MBB,JWH | Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | Remedy Spacer | |
22 | 00855195006500 | RKFMXL | Remedy Femoral Component 84mm | MBB,JWH | Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | Remedy Spacer | |
23 | 00855195006494 | UNITE40 | Unite AB Bone Cement | MBB,LOD | Bone Cement, Antibiotic,Bone Cement | 2 | Remedy Spacer | |
24 | 00855195006487 | RSHSLG | Remedy Modular Humeral Stem Large | MBB,KWS | Bone Cement, Antibiotic,Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | Remedy Spacer | |
25 | 00855195006470 | RSHSMD | Remedy Modular Humeral Stem Medium | MBB,KWS | Bone Cement, Antibiotic,Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | Remedy Spacer | |
26 | 00855195006463 | RSHSSM | Remedy Modular Humeral Stem Small | MBB,KWS | Bone Cement, Antibiotic,Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | Remedy Spacer | |
27 | 00855195006456 | RSHHLG | Remedy Modular Humeral Head 50mm | MBB,KWS | Bone Cement, Antibiotic,Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | Remedy Spacer | |
28 | 00855195006449 | RSHHMD | Remedy Modular Humeral Head 45mm | MBB,KWS | Bone Cement, Antibiotic,Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | Remedy Spacer | |
29 | 00855195006432 | RSHHSM | Remedy Modular Humeral Head 40mm | MBB,KWS | Bone Cement, Antibiotic,Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | Remedy Spacer | |
30 | 00855195006425 | RKINLG | Remedy Tibial Insert 80mm | MBB,JWH | Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | Remedy Spacer | |
31 | 00855195006418 | RKINMD | Remedy Tibial Insert 70mm | MBB,JWH | Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | Remedy Spacer | |
32 | 00855195006401 | RKINSM | Remedy Tibial Insert 60mm | MBB,JWH | Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | Remedy Spacer | |
33 | 00855195006395 | RKFMLG | Remedy Femoral Component 74mm | MBB,JWH | Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | Remedy Spacer | |
34 | 00855195006388 | RKFMMD | Remedy Femoral Component 64mm | JWH,MBB | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer,Bone Cement, Antibiotic | 2 | Remedy Spacer | |
35 | 00855195006371 | RKFMSM | Remedy Femoral Component 54mm | JWH,MBB | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer,Bone Cement, Antibiotic | 2 | Remedy Spacer | |
36 | 00855195006364 | RKTBLG | Remedy Tibial Component 80mm | MBB,JWH | Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | Remedy Spacer | |
37 | 00855195006340 | RKTBSM | Remedy Tibial Component 60mm | MBB,JWH | Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Bone Cement, Antibiotic,Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | Remedy Spacer | |
38 | 00855195006333 | RHLSLG | Remedy Modular Long Stem Large | 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 | Remedy Spacer | |
39 | 00855195006326 | RHLSMD | Remedy Modular Long Stem Medium | 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 | Remedy Spacer | |
40 | 00855195006319 | RHLSSM | Remedy Modular Long Stem Small | 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 | Remedy Spacer | |
41 | 00855195006302 | RHSTLG | Remedy Modular Stem Large | 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 | Remedy Spacer | |
42 | 00855195006296 | RHSTMD | Remedy Modular Stem Medium | 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 | Remedy Spacer | |
43 | 00855195006289 | RHSTSM | Remedy Modular Stem Small | 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 | Remedy Spacer | |
44 | 00855195006272 | RHHDLG | Remedy Modular Head 60mm | 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 | Remedy Spacer | |
45 | 00855195006265 | RHHDMD | Remedy Modular Head 54mm | 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 | Remedy Spacer | |
46 | 00855195006258 | RHHDSM | Remedy Modular Head 46mm | 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 | Remedy Spacer | |
47 | 00855195006234 | RSHSLG | Remedy Shoulder Humeral Stem Large | KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | Remedy Spacer | |
48 | 00855195006227 | RSHSMD | Remedy Shoulder Humeral Stem Medium | KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | Remedy Spacer | |
49 | 00855195006210 | RSHSSM | Remedy Shoulder Humeral Stem Small | KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | Remedy Spacer | |
50 | 00855195006203 | RSHHLG | Remedy Shoulder Humeral Head 50mm | KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | Remedy Spacer |
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 | 17613327261100 | 0937-8-205 | 0937-8-205 | EXETER MIS HALF MOON FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
17 | 17613327261100 | 0937-8-205 | 0937-8-205 | EXETER MIS HALF MOON FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
18 | 17613327261100 | 0937-8-205 | 0937-8-205 | EXETER MIS HALF MOON FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
19 | 17613327141358 | 0937-3-215 | 0937-3-215 | EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
20 | 17613327141358 | 0937-3-215 | 0937-3-215 | EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
21 | 17613327141358 | 0937-3-215 | 0937-3-215 | EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
22 | 17613327141310 | 0937-3-225 | 0937-3-225 | EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
23 | 17613327141310 | 0937-3-225 | 0937-3-225 | EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
24 | 17613327141310 | 0937-3-225 | 0937-3-225 | EXETER MIS HORSE COLLAR FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
25 | M7161112128590 | 111212859 | 111-21-2859 | Bipolar Head size 59 | OrthoMedFlex | ORTHOMEDFLEX LLC |
26 | M7161112128580 | 111212858 | 111-21-2858 | Bipolar Head size 58 | OrthoMedFlex | ORTHOMEDFLEX LLC |
27 | M7161112128570 | 111212857 | 111-21-2857 | Bipolar Head size 57 | OrthoMedFlex | ORTHOMEDFLEX LLC |
28 | M7161112128560 | 111212856 | 111-21-2856 | Bipolar Head size 56 | OrthoMedFlex | ORTHOMEDFLEX LLC |
29 | M7161112128550 | 111212855 | 111-21-2855 | Bipolar Head size 55 | OrthoMedFlex | ORTHOMEDFLEX LLC |
30 | M7161112128540 | 111212854 | 111-21-2854 | Bipolar Head size 54 | OrthoMedFlex | ORTHOMEDFLEX LLC |
31 | M7161112128530 | 111212853 | 111-21-2853 | Bipolar Head size 53 | OrthoMedFlex | ORTHOMEDFLEX LLC |
32 | M7161112128520 | 111212852 | 111-21-2852 | Bipolar Head size 52 | OrthoMedFlex | ORTHOMEDFLEX LLC |
33 | M7161112128510 | 111212851 | 111-21-2851 | Bipolar Head size 51 | OrthoMedFlex | ORTHOMEDFLEX LLC |
34 | M7161112128500 | 111212850 | 111-21-2850 | Bipolar Head size 50 | OrthoMedFlex | ORTHOMEDFLEX LLC |
35 | M7161112128490 | 111212849 | 111-21-2849 | Bipolar Head size 49 | OrthoMedFlex | ORTHOMEDFLEX LLC |
36 | M7161112128480 | 111212848 | 111-21-2848 | Bipolar Head size 48 | OrthoMedFlex | ORTHOMEDFLEX LLC |
37 | M7161112128470 | 111212847 | 111-21-2847 | Bipolar Head size 47 | OrthoMedFlex | ORTHOMEDFLEX LLC |
38 | M7161112128460 | 111212846 | 111-21-2846 | Bipolar Head size 46 | OrthoMedFlex | ORTHOMEDFLEX LLC |
39 | M7161112128450 | 111212845 | 111-21-2845 | Bipolar Head size 45 | OrthoMedFlex | ORTHOMEDFLEX LLC |
40 | M7161112128440 | 111212844 | 111-21-2844 | Bipolar Head size 44 | OrthoMedFlex | ORTHOMEDFLEX LLC |
41 | M7161112128430 | 111212843 | 111-21-2843 | Bipolar Head size 43 | OrthoMedFlex | ORTHOMEDFLEX LLC |
42 | M7161112128420 | 111212842 | 111-21-2842 | Bipolar Head size 42 | OrthoMedFlex | ORTHOMEDFLEX LLC |
43 | 10885862621887 | SPI-046561 | SPI-046561 | Alteon | EXACTECH, INC. | |
44 | 10885862618160 | SPI-044833 | SPI-044833 | Alteon | EXACTECH, INC. | |
45 | 10885862606624 | SPI-040324 | SPI-040324 | Alteon | EXACTECH, INC. | |
46 | 10885862606617 | SPI-040322 | SPI-040322 | Alteon | EXACTECH, INC. | |
47 | 10885862586834 | 01-001-01-0005 | 01-001-01-0005 | Alteon | EXACTECH, INC. | |
48 | 10885862586834 | 01-001-01-0005 | 01-001-01-0005 | Alteon | EXACTECH, INC. | |
49 | 10885862586827 | 01-001-01-0004 | 01-001-01-0004 | Alteon | EXACTECH, INC. | |
50 | 10885862586827 | 01-001-01-0004 | 01-001-01-0004 | Alteon | EXACTECH, INC. |