510(k) K040336 ยท HSB Rod, Fixation, Intramedullary And Accessories
SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Apr 12, 2004 |
| Received | Feb 11, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040336
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2015 | Synthes, Inc. DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractur Terminated |
HSB | None listed |
| Aug 26, 2013 | Synthes USA HQ, Inc. Synthes Trauma Nail System. The devices are indication for bone fixation. Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.