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NVM5

by NuVasive, LLC

Ref 2012022Model Clip and Activator, Single-Use

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0887517CLPACTY4 Basic UDI-DI 00887517166944UDI-DIDate11 Jan 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00887517166944 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-2684-2020 FDA Class II initiated 10 Jun 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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Neurophysiologic monitoring system
Device Name
Clip and Activator, Single-Use
Model / Reference
Clip and Activator, Single-Use, 2012022
Primary DI / UDI-DI
00887517166944
Basic UDI-DI
0887517CLPACTY4
510(k) Number
FDA Product Code
OLO, IKN, PDQ, ETN, HAW, GWF
EMDN Code
Z12011485 Surgical navigation instruments - consumables
GMDN Term
Neurophysiologic monitoring system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.4560, 890.1375, 874.1820, 882.1870
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II
SterileEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
US-MF-000007421
Authorised representative
AJW Technology Consulting GmbH DE-AR-000004999

Other devices from Nuvasive, Inc.

See all devices from Nuvasive, Inc. →

Properties

  • Sterile YesEUDAMEDNoGUDID
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No