510(k) K233830 · GEI Electrosurgical, Cutting & Coagulation & Accessories
OsteoCool 2.0 RF Ablation System
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Feb 28, 2024 |
| Received | Dec 1, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233830
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.