Clearance Summary
OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System received FDA 510(k) clearance under submission number K253656, sponsored by Medtronic Sofamor Danek USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2026-06-05.
- Submission: K253656
- Applicant / Sponsor: Medtronic Sofamor Danek USA, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2026-06-05
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.