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VERTEX® Reconstruction System 6958752PT

by Medtronic Sofamor Danek, Inc.

VERTEX® Reconstruction System 6958752PT is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K083071 on 14 Nov 2008 and listed in FDA GUDID since 27 Jul 2015 (UDI-DI 00613994356635), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K083071

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00613994356635 UDI-DI Date27 Jul 2015ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK083071 Date14 Nov 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K083071 decided 14 Nov 2008 Active
  • FDA GUDID UDI-DI 00613994356635 listed 27 Jul 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-1826-2016 FDA Class II initiated 1 Apr 2016

    Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

Timeline

3 dated events

  1. Cleared FDA 510(k) K083071
  2. Listed FDA GUDID 00613994356635
  3. Recall initiated FDA recalls Z-1826-2016

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VERTEX® Reconstruction System
Generic name
Bone-screw internal spinal fixation system, non-sterile
Model / reference
6958752PT
Primary DI / UDI-DI
00613994356635
510(k) Number
FDA product code
KWP
GMDN term
Bone-screw internal spinal fixation system, non-sterile
Device class
Class II
Regulation number
888.3050
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K083071)

and 8 more cleared under K083071

Similar devices

Other devices filed under FDA product code KWP (APPLIANCE, FIXATION, SPINAL INTERLAMINAL).

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)