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Bendini 8210005

by NuVasive, LLC

Bendini 8210005 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 00887517285263), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K143641

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887517285263 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK143641 Date27 Mar 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K143641 decided 27 Mar 2015 Active
  • FDA GUDID UDI-DI 00887517285263 listed 26 Sep 2016 Listed

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.

Timeline

3 dated events

  1. Cleared FDA 510(k) K143641
  2. Listed FDA GUDID 00887517285263
  3. Recall initiated FDA recalls Z-2684-2020

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bendini
Generic name
Spinal rod bending system
Model / reference
8210005
Primary DI / UDI-DI
00887517285263
510(k) Number
FDA product code
PDQ, GWF, OLO, IKN, ETN, HAW
GMDN term
Spinal rod bending system
Device class
Class II
Regulation number
874.1820, 882.1870, 882.4560, 890.1375
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal rod bending system

Cleared under the same submission (K143641)

and 8 more cleared under K143641

Similar devices

Other devices filed under FDA product code PDQ (Neurosurgical nerve locator).

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See all devices from NuVasive, LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)