510(k) K083392 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
NOVATION 12/14 CEMENTED FEMORAL STEMS
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Dec 17, 2008 |
| Received | Nov 17, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083392
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2016 | Exactech, Inc. Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15. Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.