510(k) K222056 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
| Applicant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Jan 26, 2023 |
| Received | Jul 12, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222056
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2024 | Howmedica Osteonics Corp. Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00; Open, Classified |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.