510(k) K991915 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
MODULAR RADIAL HEAD
| Applicant | Wrightmedicaltechnologyinc, Arlington TN, US |
| Decision | Substantially Equivalent, Sep 3, 1999 |
| Received | Jun 7, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991915
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2022 | Wright Medical Technology, Inc. stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It co Open, Classified |
KWI | None listed |
| Oct 4, 2022 | Wright Medical Technology, Inc. stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It Open, Classified |
KWI | None listed |
| Aug 26, 2020 | Wright Medical Technology Inc EVOLVE STEM 8.5MM
Model # 496S085 Terminated |
KWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.