OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System— 510(k) K253656
Substantially EquivalentMedtronic Sofamor Danek USA, Inc.
FDA 510(k) clearance K253656 for OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System, Substantially Equivalent on 2026-06-05. Applicant: Medtronic Sofamor Danek USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Recent devices under product code GEI
view allMore clearances from Medtronic Sofamor Danek USA, Inc.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.