510(k) K152431 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating
| Applicant | Waldemar Link GmbH & Co. KG, Hamburg, DE |
| Decision | Substantially Equivalent, May 9, 2016 |
| Received | Aug 26, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152431
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO SLED KNEE FEM COMP, SMALL
Item Number: 15-2220/40 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL
Item Number: 15-2220/46 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO SLED KNEE FEM COMP, MEDIUM
Item Number: 15-2220/52 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO SLED KNEE FEM COMP, LARGE
Item Number: 15-2220/60 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM
Item Number: 15-2230/02 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM
Item Number: 15-2230/03 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM
Item Number: 15-2230/04 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM
Item Number: 15-2230/06 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM
Item Number: 15-2230/07 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM
Item Number: 15-2230/08 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM
Item Number: 15-2230/10 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM
Item Number: 15-2230/11 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM
Item Number: 15-2230/12 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM
Item Number: 15-2230/13 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM
Item Number: 15-2230/14 Open, Classified |
KRO | None listed |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM
Item Number: 15-2230/15 Open, Classified |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.