510(k) K123401 ยท HSB Rod, Fixation, Intramedullary And Accessories
GAMMA3 AND T2 RECON TARGETING DEVICES
| Applicant | Stryker Trauma AG, Mahwah NJ, US |
| Decision | Substantially Equivalent, Jan 23, 2013 |
| Received | Nov 5, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123401
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2016 | Stryker Howmedica Osteonics Corp. Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread
Product Usage:
Intended for the temporary stabilization of bone segments or fragments. Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.