510(k) K092190 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, May 11, 2010 |
| Received | Jul 21, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092190
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2014 | Synthes, Inc. Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components. Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.