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Fortex Pedicle Screw System X022-0140

by Xtant Medical Holdings, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM697X02201401 UDI-DIDate14 Oct 2015ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Fortex Pedicle Screw System
Generic Name
Surgical screwdriver, reusable
Model / Reference
X022-0140
Primary DI / UDI-DI
M697X02201401
FDA Product Code
MNH, MNI
GMDN Term
Surgical screwdriver, reusable
Device Class
Class II
Regulation Number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical screwdriver, reusable

Other devices from Xtant Medical Holdings, Inc.

See all devices from Xtant Medical Holdings, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No