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Fortex Pedicle Screw System X064-0006

by Xtant Medical Holdings, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM697X06400061 UDI-DIDate19 Oct 2015ListedStatusListed GUDID: in commercial distribution

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.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Fortex Pedicle Screw System
Generic Name
Spinal bone screw, non-bioabsorbable
Model / Reference
X064-0006
Primary DI / UDI-DI
M697X06400061
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 — 4.75 Millimeter
Length — 55 Millimeter

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Category: Spinal bone screw, non-bioabsorbable

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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