510(k) K050636 ยท HWC Screw, Fixation, Bone
SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Apr 21, 2005 |
| Received | Mar 11, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050636
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2018 | Synthes (USA) Products LLC 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118
DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.