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Fortify 151.931

by Globus Medical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889095046236 UDI-DI Date13 Feb 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Fortify
Generic Name
Vertebral body prosthesis
Model / Reference
151.931
Primary DI / UDI-DI
00889095046236
510(k) Number
FDA Product Code
MQP
GMDN Term
Vertebral body prosthesis
Device Class
Class II
Regulation Number
888.3060
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Width — 45 Millimeter
Depth — 18 Millimeter

Related devices

Category: Vertebral body prosthesis

Cleared under the same submission (K112756)

Show all (12)

Other devices from Globus Medical, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Lot / Batch Number

Other properties (10)

  • Contains Latex: No
  • Prescription Use: 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