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Modification to Verte-Stack

by Medtronic Sofamor Danek, Inc.

510(k) K040422

Modification to Verte-Stack is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K040422 on 19 Mar 2004, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK040422 Date19 Mar 2004ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MQP
FDA applicant
Medtronic Sofamor Danek
Device class
Class II
Regulation
21 CFR Part 888.3060
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Devices cleared under K040422

4 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K040422
UDI-DISize and differences
907-430
MEDTRONIC SOFAMOR DANEK, INC.
907-43000681490499866 —On the market
9074121
MEDTRONIC SOFAMOR DANEK, INC.
907412100721902478420 —On the market
9074122
MEDTRONIC SOFAMOR DANEK, INC.
907412200721902478444 —On the market
TANGENT® Plus Reusable Instruments 9076240
MEDTRONIC SOFAMOR DANEK, INC.
907624000613994115294 —On the market

Similar devices

Other devices filed under FDA product code MQP (Spinal Vertebral Body Replacement Device).

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