510(k) K895886 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM
| Applicant | Biopro, Inc., Port Huron MI, US |
| Decision | Substantially Equivalent, Dec 1, 1989 |
| Received | Oct 5, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895886
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2025 | BioPro, Inc. BioPro Endo Head (Metal uni-polar, 38-55)
Product Number/Description
10179 ENDO MD 38
10180 ENDO MD 41
10181 ENDO MD 43
10182 ENDO MD 45
10183 ENDO MD 47
10184 ENDO MD 49
10185 ENDO MD 51
10186 ENDO Open, Classified |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.