510(k) K912641 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
BIOPRO ZIRALLOY MODULAR FEMORAL HEADS
| Applicant | Biopro, Inc., Port Huron MI, US |
| Decision | Substantially Equivalent, Nov 27, 1991 |
| Received | Jun 14, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912641
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2025 | BioPro, Inc. BioPro Femoral Head (Ceramic heads 28-30)
Product ID/Description
19023 HEAD FEMORAL CERAMIC 28MM -3
19024 HEAD FEMORAL CERAMIC 28MM +0
19025 HEAD FEMORAL CERAMIC 32MM -3
19026 HEAD FEMORAL CERAMIC 32 Open, Classified |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.