945OPM660
by Medtronic Sofamor Danek, Inc.
945OPM660 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K061113 on 23 May 2006 and listed in FDA GUDID since 14 Jan 2018 (UDI-DI 00643169071629), 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 | Number00643169071629 | Date14 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK061113 | Date23 May 2006 | StatusActive |
Official records
- AccessGUDID record 00643169071629
- FDA 510(k) database K061113
Across registries
- FDA 510(k) K061113 decided 23 May 2006 Active
- FDA GUDID UDI-DI 00643169071629 listed 14 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K061113
- Listed FDA GUDID 00643169071629
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Nerve-locating system
- Model / reference
- 945OPM660
- Primary DI / UDI-DI
- 00643169071629
- 510(k) Number
- FDA product code
- GWF, IKN
- GMDN term
- Nerve-locating system
- Device class
- Class II
- Regulation number
- 882.1870, 890.1375
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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