510(k) K041591 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Sep 23, 2004 |
| Received | Jun 14, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041591
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2024 | Howmedica Osteonics Corp. Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement
Part Number: 72-15-0324 Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.