K233830
- 510(k) number
- K233830
- Device name
- OsteoCool 2.0 RF Ablation System
- Applicant
- Medtronic Sofamor Danek USA, Inc. TN · US
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2024-02-28
- Date received
- 2023-12-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233830.pdf
Official FDA record: K233830
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.