510(k) K041533 ยท HWC Screw, Fixation, Bone
SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Sep 1, 2004 |
| Received | Jun 8, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041533
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2016 | Synthes (USA) Products LLC 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile;
Catalog ID # 02.221.462S
Indicated for fixation of various long bones. Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.