945CEEX98
by Medtronic Sofamor Danek, Inc.
945CEEX98 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 00643169071735), 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 | Number00643169071735 | Date13 Feb 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK050798 | Date15 Aug 2005 | StatusActive |
Official records
- AccessGUDID record 00643169071735
- FDA 510(k) database K050798
Across registries
- FDA 510(k) K050798 decided 15 Aug 2005 Active
- FDA GUDID UDI-DI 00643169071735 listed 13 Feb 2018 Listed
Timeline
- Cleared FDA 510(k) K050798
- Listed FDA GUDID 00643169071735
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Nerve-locating system
- Model / reference
- 945CEEX98
- Primary DI / UDI-DI
- 00643169071735
- 510(k) Number
- FDA product code
- GWF, GWQ, GWE, GWJ, GWS
- GMDN term
- Nerve-locating system
- Device class
- Class II
- Regulation number
- 882.1870, 882.1400, 882.1890, 882.1900, 882.1420
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GWF (STIMULATOR, ELECTRICAL, EVOKED RESPONSE).
- ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress by inomed Medizintechnik GmbH
- 530626 by inomed Medizintechnik GmbH
- XL Tek Evoked Potential Headbox, Model EP-16 by Excel Tech., Ltd.
- Carefusion Nicolet EDX by Carefusion 209, Inc.
- NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM by NIHON KOHDEN AMERICA, INC.
- Pediguard Nerve Detector System by Spine Vision, Inc.
- MEB-2300A Neuropack Evoked Potential and EMG Measuring System by Nihon Kohden Corp.
- NEUROVISION JJB SYSTEM by Nuvasive, Inc.
- Magstim Rapid by Magstim Corporation US
- ST10 Progr. Evoked Response Stimulator by Teca, Inc.