510(k) K033995 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
3.5 MM LCP DISTAL HUMERUS SYSTEM
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Mar 1, 2004 |
| Received | Dec 24, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033995
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2013 | Synthes USA HQ, Inc. Synthes 3.5 MM LCP(R) Distal Humerus System
The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12 Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.