Guidance 2039912
Guidance 2039912 is a Class II device made by NuVasive, LLC, cleared under FDA 510(k) K143641 on 27 Mar 2015 and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 00887517172501), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00887517172501 | Date26 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK143641 | Date27 Mar 2015 | StatusActive |
Official records
- AccessGUDID record 00887517172501
- FDA 510(k) database K143641
Across registries
- FDA 510(k) K143641 decided 27 Mar 2015 Active
- FDA GUDID UDI-DI 00887517172501 listed 26 Sep 2016 Listed
Recalls
-
- Terminated Z-2684-2020
The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal surgery contains incorrect component, part number 1715945, SSEP harness instead of the the correct part number 1747065, NVM5 Harness, Gen 3.5 EM. This issue can result in delay in therapy or lack of EMG neuromonitoring during surgery if the surgeon elects to proceed without the NVM5.
Timeline
- Cleared FDA 510(k) K143641
- Listed FDA GUDID 00887517172501
- Recall initiated FDA recalls Z-2684-2020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Guidance
- Generic name
- Neurophysiologic monitoring system
- Model / reference
- 2039912
- Primary DI / UDI-DI
- 00887517172501
- 510(k) Number
- FDA product code
- HAW, IKN, OLO, ETN, PDQ, GWF
- GMDN term
- Neurophysiologic monitoring system
- Device class
- Class II
- Regulation number
- 882.4560, 890.1375, 874.1820, 882.1870
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Neurophysiologic monitoring system.