008958
008958 is a Class II device made by Medtronic, Inc., cleared under FDA 510(k) K945461 on 3 Feb 1995 and listed in FDA GUDID since 6 Jul 2018 (UDI-DI 00643169843066), 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 | Number00643169843066 | Date6 Jul 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK945461 | Date3 Feb 1995 | StatusActive |
Official records
- AccessGUDID record 00643169843066
- FDA 510(k) database K945461
Across registries
- FDA 510(k) K945461 decided 3 Feb 1995 Active
- FDA GUDID UDI-DI 00643169843066 listed 6 Jul 2018 Listed
Timeline
- Cleared FDA 510(k) K945461
- Listed FDA GUDID 00643169843066
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Torque manipulation device
- Model / reference
- 008958
- Primary DI / UDI-DI
- 00643169843066
- 510(k) Number
- FDA product code
- DTL
- GMDN term
- Torque manipulation device
- Device class
- Class II
- Regulation number
- 870.4290
- GUDID distribution status
- In Commercial Distribution
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