Skip to content

TrackX

by TRACKX TECHNOLOGY Inc. 7 variants

TrackX 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 6 Jul 2022 (UDI-DI 00857088008165), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00857088008165 UDI-DI Date6 Jul 2022ListedStatusListed 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 00857088008165 listed 6 Jul 2022 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. Listed FDA GUDID 00857088008165
  3. Recall initiated FDA recalls Z-1107-2023
  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  • Withdrawn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 / reference
12 inch Tracking Collar Assembly, TX-3-3307
Primary DI / UDI-DI
00857088008165
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)