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TrackX T-Handle Snap

by TRACKX TECHNOLOGY 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850073646083 UDI-DI Date24 Oct 2025ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0260-2025 FDA Class III initiated 3 Sep 2024

    The patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the manufacturing date (2024-04-01) as the expiration date. The actual expiration date of the product is 2027-04-01. This is reflected on the carton label and sterile pouch label correctly.

    • Terminated Z-1107-2023 FDA Class II initiated 24 Oct 2022

    The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
TrackX
Generic Name
Diagnostic x-ray digital imaging system workstation application software
Model / Ref / Catalog
T-Handle Snap, 206-3TX
Primary DI / UDI-DI
00850073646083
510(k) Number
FDA Product Code
OWB
GMDN Term
Diagnostic x-ray digital imaging system workstation application software
Device Class
Class II
Regulation Number
892.1650
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K173736)

Show all (12)

Other devices from TRACKX TECHNOLOGY Inc.

See all devices from TRACKX TECHNOLOGY Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No