The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Osteocool Rf Ablation System.
| Device ID | K182497 |
| 510k Number | K182497 |
| Device Name: | OsteoCool RF Ablation System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Laveeda Leflore |
| Correspondent | Laveeda Leflore Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-12 |
| Decision Date | 2019-01-15 |
| Summary: | summary |