510(k) K042396 ยท HSB Rod, Fixation, Intramedullary And Accessories
T2 PROXIMAL HUMERAL NAIL
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Oct 8, 2004 |
| Received | Sep 2, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042396
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2014 | Stryker Howmedica Osteonics Corp. Teflon Tube, sterile
T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5
24232 Sconkidrchen, Germany
distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA
510 Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.