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Fortify 151.324S

by Globus Medical, Inc.

Fortify 151.324S is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K162315 on 9 Nov 2017 and listed in FDA GUDID since 15 Sep 2022 (UDI-DI 00889095616699), active as of 22 Oct 2026.

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

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) K162315

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 Number00889095616699 UDI-DI Date15 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162315 Date9 Nov 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162315 decided 9 Nov 2017 Active
  • FDA GUDID UDI-DI 00889095616699 listed 15 Sep 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162315
  2. Listed FDA GUDID 00889095616699

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Fortify
Generic name
Vertebral body prosthesis
Model / reference
151.324S
Primary DI / UDI-DI
00889095616699
510(k) Number
FDA product code
MQP, PLR
GMDN term
Vertebral body prosthesis
Device class
Class II
Regulation number
888.3060
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vertebral body prosthesis

Cleared under the same submission (K162315)

and 8 more cleared under K162315

Similar devices

Other devices filed under FDA product code MQP (Spinal vertebral body replacement device).

Other devices from Globus Medical, Inc.

See all devices from Globus Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)