510(k) K915613 ยท HWC Screw, Fixation, Bone
BONE SCREW 3.5 MM
| Applicant | Acu Med, Inc., Beaverton OR, US |
| Decision | Substantially Equivalent for Some Indications, Feb 13, 1992 |
| Received | Dec 16, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915613
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.