OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System
Device Facts
| Record ID | K253656 |
|---|---|
| Device Name | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Jun 5, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
