510(k) K103002 ยท HSB Rod, Fixation, Intramedullary And Accessories
SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Mar 2, 2011 |
| Received | Oct 8, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103002
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2012 | Synthes USA HQ, Inc. 4.5mm TI Multiloc Screw Length 38MM-Sterile
Expiration: 04/29/2012
REF 04.019.038S
Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132
4.5MM TI Multiloc Screw Length Terminated |
HSB | None listed |
| Jul 23, 2012 | Synthes USA HQ, Inc. 4.5mm TI Multiloc Screw Length 28MM-Sterile
Expiration: 04/29/2012
REF 04.019.028S
Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132
4.5MM TI Multiloc Screw Length Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.