510(k) K031428 ยท LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Aug 8, 2003 |
| Received | May 6, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031428
| 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.