510(k) K942341 ยท HWC Screw, Fixation, Bone
CANNULATED CANCELLOUS BONE SCREW
| Applicant | Acu Med, Inc., Beaverton OR, US |
| Decision | Substantially Equivalent for Some Indications, Dec 5, 1994 |
| Received | May 16, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942341
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2008 | Acumed LLC Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in part, "Congruent Plate System Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.