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Fortex Pedicle Screw System X064-0090-DL

by Xtant Medical Holdings, Inc. GUDID

Listed FDA GUDID listing, no authorization on record Open recall

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM697X0640090DL1 UDI-DIDate26 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  • Withdrawn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

4 recalls · 1 ongoing · FDA

    • Ongoing Z-1773-2026 FDA Class II initiated 18 Feb 2026

    Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.

    • Terminated Z-1884-2017 FDA Class II initiated 12 Apr 2017

    The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium.

    • Terminated Z-1823-2015 FDA Class II initiated 7 Apr 2015

    The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.

    • Terminated Z-1512-2015 FDA Class II initiated 11 Mar 2015

    One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.

Specification

GUDID

Trade Name
Fortex Pedicle Screw System
Generic Name
Spinal bone screw, non-bioabsorbable
Model / Reference
X064-0090-DL
Primary DI / UDI-DI
M697X0640090DL1
510(k) Number
FDA Product Code
MNH, MNI
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 5.5 Millimeter
Length — 50 Millimeter

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Other devices from Xtant Medical Holdings, Inc.

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Properties

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

Other properties (10)

  • Sterile: 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