510(k) K123890 ยท HWC Screw, Fixation, Bone
ACUMED CANNULATED SCREW SYSTEM
| Applicant | Acumed, LLC, Hillsboro OR, US |
| Decision | Substantially Equivalent, Mar 18, 2013 |
| Received | Dec 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123890
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 9, 2022 | Acumed LLC 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010 Completed |
HWC | None listed |
| Mar 9, 2022 | Acumed LLC 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012 Completed |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.