945RSE1000
by Medtronic Sofamor Danek, Inc.
945RSE1000 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K850108 on 11 Apr 1985 and listed in FDA GUDID since 17 Apr 2016 (UDI-DI 00643169267824), 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 | Number00643169267824 | Date17 Apr 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK850108 | Date11 Apr 1985 | StatusActive |
Official records
- AccessGUDID record 00643169267824
- FDA 510(k) database K850108
Across registries
- FDA 510(k) K850108 decided 11 Apr 1985 Active
- FDA GUDID UDI-DI 00643169267824 listed 17 Apr 2016 Listed
Timeline
- Cleared FDA 510(k) K850108
- Listed FDA GUDID 00643169267824
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Nerve-locating system
- Model / reference
- 945RSE1000
- Primary DI / UDI-DI
- 00643169267824
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Nerve-locating system
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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