Data / Medical devices / United States / TRACKX TECHNOLOGY Inc.

TRACKX TECHNOLOGY Inc.: FDA-registered device maker in Hillsborough, NC, United States, 2 510(k) clearances

Name: TRACKX TECHNOLOGY Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

TRACKX TECHNOLOGY Inc. is registered with the FDA (registration 3014391847) in Hillsborough, NC, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 5, 2020. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014391847
Address: 437 Dimmocks Mill Rd Ste 28, Hillsborough, NC, United States, 27278
Owner or operator: TrackX Technology Inc. (10057101)
Roles: Manufacturer
First device listed: March 5, 2018
Registered through: 2026
Brand names listed: TrackX

Devices it lists

Device	Product code	Class	Role	Source
Interventional Fluoroscopic X-Ray System	OWB	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 5, 2020	K200360	TrackX	OWB	Substantially Equivalent	Track X Technology, LLC	accessdata.fda.gov
February 28, 2018	K173736	TrackX	OWB	Substantially Equivalent	Track X Technology, LLC	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 3, 2024	95424	Class III	Ongoing	Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when use	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.	accessdata.fda.gov
October 24, 2022	91338	Class II	Terminated	TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.	The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.	accessdata.fda.gov

Compare with other makers

Updated October 30, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.