510(k) K012945 ยท HWC Screw, Fixation, Bone
SYNTHES 2.4 MM CANNULATED SCREW
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Dec 3, 2001 |
| Received | Sep 4, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012945
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2013 | Oculus Innovative Sciences Inc Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz..
RX only, Professional Sample, Not for Sale.
Pre-printed tube: MS31071,
Shelf carton: PL51091-08
Atrapro Antipruritic HydroGel is ind Terminated |
FRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.