VERTE-STACK® Spinal System 8915416

by Medtronic Sofamor Danek, Inc.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00721902379598 UDI-DI	Date30 Jul 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK021791	Date26 Aug 2002Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: VERTE-STACK® Spinal System
Generic name: Vertebral body prosthesis
Model / reference: 8915416

Primary DI / UDI-DI: 00721902379598
510(k) Number: K021791
FDA product code: MQP
GMDN term: Vertebral body prosthesis

Device class: Class II
Regulation number: 888.3060
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number

Other properties (10)

Sterilise before use: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Expiration date: No
Manufacturing date: No