OsteoCool™ RF Ablation System OC01
by Medtronic Sofamor Danek, Inc. 2 variants
OsteoCool™ RF Ablation System OC01 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K152057 on 24 Nov 2015 and listed in FDA GUDID since 31 Mar 2016 (UDI-DI 00643169546301), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00643169546301 | Date31 Mar 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152057 | Date24 Nov 2015 | StatusActive |
Official records
- AccessGUDID record 00643169546301
- FDA 510(k) database K152057
Across registries
- FDA 510(k) K152057 decided 24 Nov 2015 Active
- FDA GUDID UDI-DI 00643169546301 listed 31 Mar 2016 Listed
Timeline
- Cleared FDA 510(k) K152057
- Listed FDA GUDID 00643169546301
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- OsteoCool™ RF Ablation System
- Generic name
- Percutaneous radio-frequency ablation system generator
- Model / reference
- OC01
- Primary DI / UDI-DI
- 00643169546301
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Percutaneous radio-frequency ablation system generator
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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