945AE102
by Medtronic Sofamor Danek, Inc.
945AE102 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K050798 on 15 Aug 2005 and listed in FDA GUDID since 13 Feb 2018 (UDI-DI 00643169071773), 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 | Number00643169071773 | Date13 Feb 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK050798 | Date15 Aug 2005 | StatusActive |
Official records
- AccessGUDID record 00643169071773
- FDA 510(k) database K050798
Across registries
- FDA 510(k) K050798 decided 15 Aug 2005 Active
- FDA GUDID UDI-DI 00643169071773 listed 13 Feb 2018 Listed
Timeline
- Cleared FDA 510(k) K050798
- Listed FDA GUDID 00643169071773
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Nerve-locating system
- Model / reference
- 945AE102
- Primary DI / UDI-DI
- 00643169071773
- 510(k) Number
- FDA product code
- GWF, GWQ, GWS, GWJ, GWE
- GMDN term
- Nerve-locating system
- Device class
- Class II
- Regulation number
- 882.1870, 882.1400, 882.1420, 882.1900, 882.1890
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GWF (STIMULATOR, ELECTRICAL, EVOKED RESPONSE).
- SEN-4100 ELECTRIC STIMULATOR by NIHON KOHDEN AMERICA, INC.
- Delphi Stimulator by Quantalx Neuroscience
- Cadwell Guardian 199332-000 by Cadwell Industries, Inc.
- NIM Vital Nerve Integrity Monitor by Medtronic Xomed Inc
- Coils, Models MCF-B65, MCF-75, MCF-125 and COOL-B65 by Tonica Elektronik A/S
- MagPro Accessories Flex Arm-Long 9016B0171 by Tonica Elektronik A/S
- Electroencephalograph (EEG) by Moberg Medical, Inc.
- ENT NIM Vital NIM4CPB2 by Medtronic Xomed Inc
- Neural Magnetic Stimulator D190 by Tracor Northern, Inc.
- ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress by inomed Medizintechnik GmbH