510(k) K251132 ยท HRS Plate, Fixation, Bone
The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws
| Applicant | Acumed, LLC, Hillsboro OR, US |
| Decision | Substantially Equivalent, Jul 14, 2025 |
| Received | Apr 11, 2025 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K251132
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 23, 2026 | Acumed LLC Acumed Hexalob Screw various sizes:
REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw;
3070-27009 2.7mm x 9mm NL Hexalobe Screw;
3070-27010 2.7mm x 10mm NL Hexalobe Screw;
3070-27011 2.7mm x 11m Open, Classified |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.