No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | M684EPT6514LWD1 | EPT6514LWD | EPT6514LWD | HWT | TEMPLATE | 1 | PS | |
2 | M684PNV036111 | PNV03611 | PNV03611 | JWH,MBH,OOG | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER,Knee arthroplasty implantation system | 2 | PROPHECY | |
3 | M684PHA062121 | PHA06212 | PHA06212 | LPH,LZO | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED,Prosthesis, PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED,Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 2 | PROCOTYL | |
4 | M684KTIBTL2U1 | KTIBTL2U | KTIBTL2U | HWT | TEMPLATE | 1 | ADVANCE® | |
5 | M684KTTINP251 | KTTINP25 | KTTINP25 | HRY,JWH | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER,PROSTH PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | ADVANCE | |
6 | M684KTRLBF601 | KTRLBF60 | KTRLBF60 | HWT | TEMPLATE | 1 | ODYSSEY® | |
7 | M684KITLL1071 | KITLL107 | KITLL107 | HWT | TEMPLATE | 1 | ADVANCE® | |
8 | M684KIDT414L1 | KIDT414L | KIDT414L | HWT | TEMPLATE | 1 | ADVANCE® | |
9 | M684KIDT412R1 | KIDT412R | KIDT412R | HWT | TEMPLATE | 1 | ADVANCE® | |
10 | M684KFPCMR101 | KFPCMR10 | KFPCMR10 | HWT | TEMPLATE | 1 | ODYSSEY® | |
11 | M684ETRKN4SL1 | ETRKN4SL | ETRKN4SL | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | EVOLUTION® | |
12 | M684EAT4212L1 | EAT4212L | EAT4212L | HWT | TEMPLATE | 1 | EVOLUTION® | |
13 | M684EFSAN1PR1 | EFSAN1PR | EFSAN1PR | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | EVOLUTION | |
14 | M684EAT7517R1 | EAT7517R | EAT7517R | HWT | TEMPLATE | 1 | EVOLUTION® | |
15 | M684EAT6310R1 | EAT6310R | EAT6310R | HWT | TEMPLATE | 1 | EVOLUTION® | |
16 | M684EAT5217R1 | EAT5217R | EAT5217R | HWT | TEMPLATE | 1 | EVOLUTION® | |
17 | M684EFXPNP4L1 | EFXPNP4L | EFXPNP4L | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | EVOLUTION | |
18 | M684E63043RL1 | E63043RL | E63043RL | PBF | Orthopaedic surgical planning and instrument guides | 2 | Evolution Revision CCK System | |
19 | M684E63048RL1 | E63048RL | E63048RL | PBF | Orthopaedic surgical planning and instrument guides | 2 | Evolution Revision CCK System | |
20 | M684E63042RL1 | E63042RL | E63042RL | PBF | Orthopaedic surgical planning and instrument guides | 2 | Evolution Revision CCK System | |
21 | M684E17046821 | E1704682 | E1704682 | PBF | Orthopaedic surgical planning and instrument guides | 2 | Evolution Revision CCK System | |
22 | M684DNFLTRA11 | DNFLTRA1 | DNFLTRA1 | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | DYNASTY® | |
23 | M684515618141 | 51561814 | 51561814 | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | MicroPort | |
24 | M684400010581 | 40001058 | 40001058 | HWT | TEMPLATE | 1 | INTERSEAL® | |
25 | M6843304LJ501 | 3304LJ50 | 3304LJ50 | HWT | TEMPLATE | 1 | DYNASTY® | |
26 | M6843658XR151 | 3658XR15 | 3658XR15 | HWT | TEMPLATE | 1 | LINEAGE® | |
27 | M684333300201 | 33330020 | 33330020 | HWA | IMPACTOR | 1 | DYNASTY® | |
28 | M6843000AG011 | 3000AG01 | 3000AG01 | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | INTERSEAL® | |
29 | M684188160521 | 18816052 | 18816052 | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | Advantim | |
30 | M684184191141 | 18419114 | 18419114 | HWT | TEMPLATE | 1 | ORTHOLOC® | |
31 | M684180700421 | 18070042 | 18070042 | HWT | TEMPLATE | 1 | SLR | |
32 | M684184101331 | 18410133 | 18410133 | FZX | Guide, surgical, instrument | 1 | Advantium | |
33 | M684PNV040491 | PNV04049 | PNV04049 | OOG,MBH,JWH | Knee arthroplasty implantation system,PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SE Knee arthroplasty implantation system,PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | PROPHECY | |
34 | M684PNV040481 | PNV04048 | PNV04048 | JWH,MBH,OOG | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER,Knee arthroplasty implantation system | 2 | PROPHECY | |
35 | M684PNV040471 | PNV04047 | PNV04047 | MBH,JWH,OOG | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,Knee arthroplasty implantation system | 2 | PROPHECY | |
36 | M684PNV040461 | PNV04046 | PNV04046 | MBH,OOG,JWH | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER,Knee arthroplasty implantation system,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | PROPHECY | |
37 | M684PNV040451 | PNV04045 | PNV04045 | JWH,OOG,MBH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,Knee arthroplasty implantation system,PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER | 2 | PROPHECY | |
38 | M684PNV040441 | PNV04044 | PNV04044 | MBH,JWH,OOG | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,Knee arthroplasty implantation system | 2 | PROPHECY | |
39 | M684PNV040431 | PNV04043 | PNV04043 | JWH,MBH,OOG | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER,Knee arthroplasty implantation system | 2 | PROPHECY | |
40 | M684PNV040421 | PNV04042 | PNV04042 | OOG,MBH,JWH | Knee arthroplasty implantation system,PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SE Knee arthroplasty implantation system,PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | PROPHECY | |
41 | M684PNV040411 | PNV04041 | PNV04041 | MBH,OOG,JWH | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER,Knee arthroplasty implantation system,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | PROPHECY | |
42 | M684PNV040401 | PNV04040 | PNV04040 | MBH,JWH,OOG | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,Knee arthroplasty implantation system | 2 | PROPHECY | |
43 | M684PNV040391 | PNV04039 | PNV04039 | JWH,OOG,MBH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,Knee arthroplasty implantation system,PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER | 2 | PROPHECY | |
44 | M684PNV040381 | PNV04038 | PNV04038 | JWH,OOG,MBH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,Knee arthroplasty implantation system,PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER | 2 | PROPHECY | |
45 | M684PNV040371 | PNV04037 | PNV04037 | JWH,OOG,MBH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,Knee arthroplasty implantation system,PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER | 2 | PROPHECY | |
46 | M684PNV040361 | PNV04036 | PNV04036 | JWH,OOG,MBH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,Knee arthroplasty implantation system,PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER | 2 | PROPHECY | |
47 | M684PNV040351 | PNV04035 | PNV04035 | MBH,OOG,JWH | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER,Knee arthroplasty implantation system,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | PROPHECY | |
48 | M684PNV040341 | PNV04034 | PNV04034 | OOG,JWH,MBH | Knee arthroplasty implantation system,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEM Knee arthroplasty implantation system,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER | 2 | PROPHECY | |
49 | M684PNV040331 | PNV04033 | PNV04033 | OOG,MBH,JWH | Knee arthroplasty implantation system,PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SE Knee arthroplasty implantation system,PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | PROPHECY | |
50 | M684PNV040321 | PNV04032 | PNV04032 | MBH,OOG,JWH | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER,Knee arthroplasty implantation system,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | PROPHECY |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B278SB4044V03M0 | SB-4044V-03M | SB-4044V-03M | MODULAR REDUCED RESECTION COLLAR, 40MM X 44MM | ELEOS Limb Salvage System | ONKOS SURGICAL, INC. |
2 | B278SB3640V03M0 | SB-3640V-03M | SB-3640V-03M | MODULAR REDUCED RESECTION COLLAR, 36MM X 40MM | ELEOS Limb Salvage System | ONKOS SURGICAL, INC. |
3 | B278PB4000R03M0 | PB-4000R-03M | PB-4000R-03M | MODULAR POROUS BIOGRIP® COLLAR, 40MM, HA COATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
4 | B278PB3600R03M0 | PB-3600R-03M | PB-3600R-03M | MODULAR POROUS BIOGRIP® COLLAR, 36MM, HA COATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
5 | B278PB3200R03M0 | PB-3200R-03M | PB-3200R-03M | MODULAR POROUS BIOGRIP® COLLAR, 32MM, HA COATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
6 | B278PB2800R03M0 | PB-2800R-03M | PB-2800R-03M | MODULAR POROUS BIOGRIP® COLLAR, 28MM, HA COATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
7 | B278PB2400R03M0 | PB-2400R-03M | PB-2400R-03M | MODULAR POROUS BIOGRIP® COLLAR, 24MM, HA COATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
8 | B278HR3000103M0 | HR-30001-03M | HR-30001-03M | ELEOS MODULAR COLLAR LOCKING RING AND IMPACTOR TIP | ELEOS Limb Salvage System | ONKOS SURGICAL, INC. |
9 | B278HR3000003M0 | HR-30000-03M | HR-30000-03M | ELEOS MODULAR COLLAR LOCKING RING | ELEOS Limb Salvage System | ONKOS SURGICAL, INC. |
10 | B278HC1712003M0 | HC-17120-03M | HC-17120-03M | SEGMENTAL COLLAR STEM, CEMENTED, 17MM X 100MM | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
11 | B278HC1512003M0 | HC-15120-03M | HC-15120-03M | SEGMENTAL COLLAR STEM, CEMENTED, 15MM X 100MM | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
12 | B278HC1312003M0 | HC-13120-03M | HC-13120-03M | SEGMENTAL COLLAR STEM, CEMENTED, 13MM X 100MM | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
13 | B278HC1112003M0 | HC-11120-03M | HC-11120-03M | SEGMENTAL COLLAR STEM, CEMENTED, 11MM X 100MM | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
14 | B278HC1010003M0 | HC-10100-03M | HC-10100-03M | SEGMENTAL COLLAR STEM, CEMENTED, 10MM X 100MM | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
15 | B278HC0910003M0 | HC-09100-03M | HC-09100-03M | SEGMENTAL COLLAR STEM, CEMENTED, 9MM X 100MM | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
16 | B278HB4000R03M0 | HB-4000R-03M | HB-4000R-03M | MODULAR POROUS BIOGRIP® COLLAR, 40MM, UNCOATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
17 | B278HB3600R03M0 | HB-3600R-03M | HB-3600R-03M | MODULAR POROUS BIOGRIP® COLLAR, 36MM, UNCOATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
18 | B278HB3200R03M0 | HB-3200R-03M | HB-3200R-03M | MODULAR POROUS BIOGRIP® COLLAR, 32MM, UNCOATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
19 | B278HB2800R03M0 | HB-2800R-03M | HB-2800R-03M | MODULAR POROUS BIOGRIP® COLLAR, 28MM, UNCOATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
20 | B278HB2400R03M0 | HB-2400R-03M | HB-2400R-03M | MODULAR POROUS BIOGRIP® COLLAR, 24MM, UNCOATED | ELEOS Limb Salvage System With BioGrip | ONKOS SURGICAL, INC. |
21 | 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 | |
22 | 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 | |
23 | 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 | |
24 | 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 | |
25 | 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 | |
26 | 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 | |
27 | 17613327311089 | I-H1236HA00 | I-H1236HA00 | SPECIALTY TRIDENT TRIAL CONTAINMENT SCREW-LONGER | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
28 | 17613327261100 | 0937-8-205 | 0937-8-205 | EXETER MIS HALF MOON FEMORAL CEMENT SEAL | INSTRUMENT | HOWMEDICA OSTEONICS CORP. |
29 | 17613327141358 | 0937-3-215 | 0937-3-215 | 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 | M7161112128590 | 111212859 | 111-21-2859 | Bipolar Head size 59 | OrthoMedFlex | ORTHOMEDFLEX LLC |
32 | M7161112128580 | 111212858 | 111-21-2858 | Bipolar Head size 58 | OrthoMedFlex | ORTHOMEDFLEX LLC |
33 | M7161112128570 | 111212857 | 111-21-2857 | Bipolar Head size 57 | OrthoMedFlex | ORTHOMEDFLEX LLC |
34 | M7161112128560 | 111212856 | 111-21-2856 | Bipolar Head size 56 | OrthoMedFlex | ORTHOMEDFLEX LLC |
35 | M7161112128550 | 111212855 | 111-21-2855 | Bipolar Head size 55 | OrthoMedFlex | ORTHOMEDFLEX LLC |
36 | M7161112128540 | 111212854 | 111-21-2854 | Bipolar Head size 54 | OrthoMedFlex | ORTHOMEDFLEX LLC |
37 | M7161112128530 | 111212853 | 111-21-2853 | Bipolar Head size 53 | OrthoMedFlex | ORTHOMEDFLEX LLC |
38 | M7161112128520 | 111212852 | 111-21-2852 | Bipolar Head size 52 | OrthoMedFlex | ORTHOMEDFLEX LLC |
39 | M7161112128510 | 111212851 | 111-21-2851 | Bipolar Head size 51 | OrthoMedFlex | ORTHOMEDFLEX LLC |
40 | M7161112128500 | 111212850 | 111-21-2850 | Bipolar Head size 50 | OrthoMedFlex | ORTHOMEDFLEX LLC |
41 | M7161112128490 | 111212849 | 111-21-2849 | Bipolar Head size 49 | OrthoMedFlex | ORTHOMEDFLEX LLC |
42 | M7161112128480 | 111212848 | 111-21-2848 | Bipolar Head size 48 | OrthoMedFlex | ORTHOMEDFLEX LLC |
43 | M7161112128470 | 111212847 | 111-21-2847 | Bipolar Head size 47 | OrthoMedFlex | ORTHOMEDFLEX LLC |
44 | M7161112128460 | 111212846 | 111-21-2846 | Bipolar Head size 46 | OrthoMedFlex | ORTHOMEDFLEX LLC |
45 | M7161112128450 | 111212845 | 111-21-2845 | Bipolar Head size 45 | OrthoMedFlex | ORTHOMEDFLEX LLC |
46 | M7161112128440 | 111212844 | 111-21-2844 | Bipolar Head size 44 | OrthoMedFlex | ORTHOMEDFLEX LLC |
47 | M7161112128430 | 111212843 | 111-21-2843 | Bipolar Head size 43 | OrthoMedFlex | ORTHOMEDFLEX LLC |
48 | M7161112128420 | 111212842 | 111-21-2842 | Bipolar Head size 42 | OrthoMedFlex | ORTHOMEDFLEX LLC |
49 | 10885862586834 | 01-001-01-0005 | 01-001-01-0005 | Alteon | EXACTECH, INC. | |
50 | 10885862586827 | 01-001-01-0004 | 01-001-01-0004 | Alteon | EXACTECH, INC. |