510(k) K110789 ยท JDQ Cerclage, Fixation
SYNTHES STERNAL ZIPFIX SYSTEM
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Jul 28, 2011 |
| Received | Mar 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110789
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2015 | Synthes (USA) Products LLC Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the ste Terminated |
JDQ | None listed |
| Aug 27, 2015 | Synthes (USA) Products LLC Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the stern Terminated |
JDQ | None listed |
| Oct 30, 2013 | Synthes USA HQ, Inc. Synthes Application Instrument Sternal Zip Flex System
intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum Terminated |
JDQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.