510(k) K213328 ยท HSB Rod, Fixation, Intramedullary And Accessories
Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
| Applicant | Stryker GmbH, Mahwah NJ, US |
| Decision | Substantially Equivalent, Feb 11, 2022 |
| Received | Oct 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213328
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2025 | Stryker GmbH Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S. Open, Classified |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.