510(k) K122455 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM
| Applicant | Synthes, West Chester PA, US |
| Decision | Substantially Equivalent, Apr 11, 2013 |
| Received | Aug 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122455
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2015 | Synthes (USA) Products LLC Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forea Terminated |
KTT | None listed |
| 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.