510(k) K060731 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
EVOLVE MODULAR RADIAL HEAD
| Applicant | Wrightmedicaltechnologyinc, Arlington TN, US |
| Decision | Substantially Equivalent, Apr 19, 2006 |
| Received | Mar 20, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060731
| 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 |
| Dec 27, 2019 | Wright Medical Technology, Inc. WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220 Terminated |
KWI | None listed |
| Dec 27, 2019 | Wright Medical Technology, Inc. WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222 Terminated |
KWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.