510(k) K082844 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Nov 25, 2008 |
| Received | Sep 26, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082844
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2023 | Encore Medical, LP DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443 Open, Classified |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.