K253656
- 510(k) number
- K253656
- Device name
- OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
- Applicant
- Medtronic Sofamor Danek USA, Inc. TN · US
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2026-06-05
- Date received
- 2025-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K253656.pdf
Official FDA record: K253656
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.