510(k) K034002 ยท HSB Rod, Fixation, Intramedullary And Accessories
GAMMA3 NAIL SYSTEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Jan 15, 2004 |
| Received | Dec 24, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K034002
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2010 | Stryker Howmedica Osteonics Corp. Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees;
Sterile, TI Alloy, Implant; Catalog number 3225-0360S.
Stryker Trauma GmbH, 24232 Schenjrchen, Germany;
distributed in USA by Howmedica Osteonic Terminated |
HSB | None listed |
| Dec 1, 2005 | Stryker Howmedica Osteonics Corp. Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail. Terminated |
NDH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.