510(k) K142814 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial
| Applicant | Biomet Manufacturing, LLC, Warsaw IN, US |
| Decision | Substantially Equivalent, Jun 25, 2015 |
| Received | Sep 29, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142814
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2019 | Zimmer Biomet, Inc. Orthopedic Salvage System (OSS) Hybrid Poly Tibia
Item # 151810 Terminated |
JDI | None listed |
| Jul 2, 2019 | Zimmer Biomet, Inc. Orthopedic Salvage System (OSS) Hybrid Poly Tibia
Item # 151811 Terminated |
JDI | None listed |
| Jul 2, 2019 | Zimmer Biomet, Inc. Orthopedic Salvage System (OSS) Hybrid Poly Tibia
Item # 151812 Terminated |
JDI | None listed |
| Jul 2, 2019 | Zimmer Biomet, Inc. Orthopedic Salvage System (OSS) Hybrid Poly Tibia
Item # 151813 Terminated |
JDI | None listed |
| Jul 2, 2019 | Zimmer Biomet, Inc. Orthopedic Salvage System (OSS) Hybrid Poly Tibia
Item # 151814 Terminated |
JDI | None listed |
| Jul 2, 2019 | Zimmer Biomet, Inc. Orthopedic Salvage System (OSS) Hybrid Poly Tibia
Item # 151815 Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.