510(k) K954768 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
| Applicant | Biologically Oriented Prostheses, Port Huron MI, US |
| Decision | Substantially Equivalent, Jan 18, 1996 |
| Received | Oct 17, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954768
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2025 | BioPro, Inc. BioPro Endo Head (Ceramic)
Product ID/Description
13006 ENDO MODULAR CERAMIC SH 38
13012 ENDO MODULAR CERAMIC SH 51
13013 ENDO MODULAR CERAMIC MD 38
13019 ENDO MODULAR CERAMIC MD 51
13007 ENDO MODULA Open, Classified |
LZY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.