510(k) K083827 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 13, 2009 |
| Received | Dec 23, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083827
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2017 | Zimmer Biomet, Inc. Orthopedic Salvage System (OSS) 9cm
prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
Knee System Tibial Bodies Terminated |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.