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VERTE-SPAN® Spinal System 8912200

by Medtronic Sofamor Danek, Inc.

VERTE-SPAN® Spinal System 8912200 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K010930 on 24 Oct 2001 and listed in FDA GUDID since 4 Aug 2015 (UDI-DI 00721902035289), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

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 found

in data synced 22 Oct 2026

Documents

510(k) K010930

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 Number00721902035289 UDI-DI Date4 Aug 2015ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK010930 Date24 Oct 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K010930 decided 24 Oct 2001 Active
  • FDA GUDID UDI-DI 00721902035289 listed 4 Aug 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K010930
  2. Listed FDA GUDID 00721902035289

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VERTE-SPAN® Spinal System
Generic name
Vertebral body prosthesis
Model / reference
8912200
Primary DI / UDI-DI
00721902035289
510(k) Number
FDA product code
KWQ, MQP
GMDN term
Vertebral body prosthesis
Device class
Class II
Regulation number
888.3060
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K010930)

Similar devices

Other devices filed under FDA product code KWQ (APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY).

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)