510(k) K971692 ยท KMW Handpiece, Rotary Bone Cutting
OSTEOPOWER SYSTEM AND ACCESSORIES
| Applicant | Osteomed Corp., Irving TX, US |
| Decision | Substantially Equivalent, Jun 27, 1997 |
| Received | May 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971692
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2021 | Osteomed, LLC OsteoMed OsteoPower Power Console:
-OsteoMed OsteoPower Power Console 2 REF 450-0021-00
-OsteoMed D-Power Control Console 2 REF 450-0021-01
-Power Control Console 2 REF ECOS-450-0021-00
-OsteoMed Os Open, Classified |
KMW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.