510(k) K052685 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
ORTHOPEDIC SALVAGE SYSTEM- OSS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 27, 2005 |
| Received | Sep 28, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052685
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2008 | Biomet, Inc. OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043.
Implant is part of a system used to replace the tibi Terminated |
KRO | None listed |
| Sep 17, 2008 | Biomet, Inc. Biomet OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, 75mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161044.
Implant is part of a system used to replace the tibial porti Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.