510(k) K182497 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
OsteoCool RF Ablation System
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jan 15, 2019 |
| Received | Sep 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182497
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.