510(k) K040762 ยท JDS Nail, Fixation, Bone
SYNTHES (USA) TIBIAL NAIL SYSTEM EX
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Apr 12, 2004 |
| Received | Mar 25, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040762
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2015 | Synthes, Inc. TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial Terminated |
JDS | 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.