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TrackX

by TRACKX TECHNOLOGY Inc. 7 variants

TrackX (TX-3-4079) is a Class II device made by TRACKX TECHNOLOGY Inc., cleared under FDA 510(k) K173736 on 28 Feb 2018 and listed in FDA GUDID since 13 Mar 2024 (UDI-DI 00857088008653), active as of 8 Jun 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K173736

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Jun 2026.

Regulatory status

as of registry sync 8 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00857088008653 UDI-DI Date13 Mar 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173736 Date28 Feb 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173736 decided 28 Feb 2018 Active
  • FDA GUDID UDI-DI 00857088008653 listed 13 Mar 2024 Listed

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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K173736
  2. Recall initiated FDA recalls Z-1107-2023
  3. Listed FDA GUDID 00857088008653
  4. Recall initiated FDA recalls Z-0260-2025

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Diagnostic x-ray digital imaging system workstation application software
Model / Ref / Catalog
TrackX Insight Base - NV/AT Disc Prep - MJF VS, TX-3-4079
Primary DI / UDI-DI
00857088008653
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

Category: Diagnostic x-ray digital imaging system workstation application software

Cleared under the same submission (K173736)

and 8 more cleared under K173736

Similar devices

Other devices filed under FDA product code OWB (Interventional Fluoroscopic X-Ray System).

Other devices from TRACKX TECHNOLOGY Inc.

See all devices from TRACKX TECHNOLOGY Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)