510(k) K100761 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
BIOPRO POLAR HEAD
| Applicant | Biopro, Inc., Port Huron MI, US |
| Decision | Substantially Equivalent, Dec 3, 2010 |
| Received | Mar 17, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100761
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2025 | BioPro, Inc. BioPro Bipolar Head
Product ID/Description
18130 BIPOLAR HEAD 38MM
18131 BIPOLAR HEAD 39MM
18132 BIPOLAR HEAD 40MM
18133 BIPOLAR HEAD 41MM
18134 BIPOLAR HEAD 42MM
18135 BIPOLAR HEAD 43MM
18136 BIPOLA Open, Classified |
KWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.