510(k) K052718 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
V40 BIOLOX DELTA CERAMIC FEMORAL HEADS
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Oct 27, 2005 |
| Received | Sep 29, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052718
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2022 | Howmedica Osteonics Corp. Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm
Catalog Number: 6570-0-032 Open, Classified |
LZO | None listed |
| Jan 14, 2022 | Howmedica Osteonics Corp. Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm
Catalog Number: 6570-0-232 Open, Classified |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.