510(k) K033158 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Nov 5, 2003 |
| Received | Sep 30, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033158
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.