510(k) K954186 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
SLED UNICOMPARTMENT KNEE SYSTEM
| Applicant | Link America, Inc., East Hanavor NJ, US |
| Decision | Substantially Equivalent, Jan 26, 1996 |
| Received | Sep 6, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954186
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ENDO SLED KNEE FEM COMP, SMALL
Item Number: 15-2020/40 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ENDO SLED KNEE FEM COMP, MEDIUM SMALL
Item Number: 15-2020/46 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ENDO SLED KNEE FEM COMP, MEDIUM
Item Number: 15-2020/52 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ENDO SLED KNEE FEM COMP, Large
Item Number: 15-2020/60 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 7MM X 45MM
Item Number: 15-2028/01 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 9MM X 45MM
Item Number: 15-2028/02 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 11MM X 45MM
Item Number: 15-2028/03 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 13MM X 45MM
Item Number: 15-2028/04 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 7MM X 50MM
Item Number: 15-2028/05 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 9MM X 50MM
Item Number: 15-2028/06 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 11MM X 50MM
Item Number: 15-2028/07 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 13MM X 50MM
Item Number: 15-2028/08 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 7MM X 55MM
Item Number: 15-2028/09 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 9MM X 55MM
Item Number: 15-2028/10 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 11MM X 55MM
Item Number: 15-2028/11 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 13MM X 55MM
Item Number: 15-2028/12 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 7MM X 58MM
Item Number: 15-2028/13 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 9X58MM
Item Number: 15-2028/14 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 11X58MM
Item Number: 15-2028/15 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 13X58MM
Item Number: 15-2028/16 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM
Item Number: 15-2030/02 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM
Item Number: 15-2030/03 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM
Item Number: 15-2030/04 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM
Item Number: 15-2030/06 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM
Item Number: 15-2030/07 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM
Item Number: 15-2030/08 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM
Item Number: 15-2030/10 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM
Item Number: 15-2030/11 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM
Item Number: 15-2030/12 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM
Item Number: 15-2030/13 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM
Item Number: 15-2030/14 Open, Classified |
HSX | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM
Item Number: 15-2030/15 Open, Classified |
HSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.