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TRACKX TECHNOLOGY Inc.

Last updated September 17, 2026

Information

Country: US
Address: 437 Dimmocks Mill Rd Ste 28, Hillsborough, NC, 27278
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3014391847
DUNS Number: —

Catalogue (77)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
TrackX	TrackX NV RETRACT-ADAPT - MJF VS	FDA UDI	Class II	Unknown
TrackX	ACCESS-CALIBRATOR CUP 1	FDA UDI	Class II	Active
TrackX	TrackX HOME BASE VS SNAP	FDA UDI	Class II	Active
TrackX	INSIGHT™ ARRAY-VIOLET	FDA UDI	Class II	Active
TrackX	Pointer	FDA UDI	Class II	Active
TrackX	TrackX Hudson MOD T-Handle	FDA UDI	Class II	Active
TrackX	INSIGHT™ BASE-5L	FDA UDI	Class II	Active
TrackX	NSIGHT™-6 SNAP Kit	FDA UDI	Class II	Unknown
TrackX	TrackX NV RETRACT-ADAPT - MJF VS	FDA UDI	Class II	Active
TrackX	TrackX AT INSERT-ADAPT - MJF VS	FDA UDI	Class II	Active
TrackX	Calibrator 2.0	FDA UDI	Class II	Active
TrackX	Hex Pin 6mm x 150mm	FDA UDI	Class II	Active
TrackX	TrackX SE RETRACT-ADAPT 5L - MJF VS	FDA UDI	Class II	Active
TrackX	VISION™- I+ SNAP	FDA UDI	Class II	Active
TrackX	Screw Length Calibrator	FDA UDI	Class II	Unknown
TrackX	Calibrator	FDA UDI	Class II	Unknown
TrackX	12 inch Distortion Plate Assembly; TX-3-3662	FDA UDI	Class II	Active
TrackX	ATEC Lateral Kit 3.0	FDA UDI	Class II	Unknown
TrackX	Dilator	FDA UDI	Class II	Active
TrackX	12 inch C-Arm Collar Assembly	FDA UDI	Class II	Unknown
TrackX	TrackX Home Base Pin - 6mm x 100mm	FDA UDI	Class II	Active
TrackX	9 inch Tracking Collar Assembly; TX-3-3300	FDA UDI	Class II	Active
TrackX	TrackX T-ADAPT - PEEK	FDA UDI	Class II	Active
TrackX	TrackX NV INSERT-ADAPT	FDA UDI	Class II	Active
TrackX	INSIGHT™ BASE-3.5L	FDA UDI	Class II	Active
TrackX	21 cm Flat Panel Cap Assembly	FDA UDI	Class II	Active
TrackX	9 Inch Distortion Plate Assembly; TX-3-3675	FDA UDI	Class II	Active
TrackX	INSIGHT™ ARRAY-ORANGE	FDA UDI	Class II	Active
TrackX	TrackX Insight Base - NV/AT Disc Prep - MJF VS	FDA UDI	Class II	Active
TrackX	31 cm Flat Panel Collar Assembly	FDA UDI	Class II	Active
TrackX	VISION™-V SNAP	FDA UDI	Class II	Active
TrackX	TrackX Home Base Pin - 6mm x 150mm	FDA UDI	Class II	Active
TrackX	VISION™- A SNAP	FDA UDI	Class II	Active
TrackX	31 cm Flat Panel Cap Assembly	FDA UDI	Class II	Active
TrackX	TrackX Hudson T-Handle	FDA UDI	Class II	Active
TrackX	ACCESS-CALIBRATOR CUP 2	FDA UDI	Class II	Active
TrackX	TrackX Software	FDA UDI	Class II	Active
TrackX	INSIGHT™ BASE-7L	FDA UDI	Class II	Unknown
TrackX	TrackX T-ADAPT - MJF	FDA UDI	Class II	Active
TrackX	12 inch Tracking Collar Assembly; TX-3-3307	FDA UDI	Class II	Active
TrackX	VISION-T SNAP	FDA UDI	Class II	Active
TrackX	INSIGHT™ BASE FLEX-25	FDA UDI	Class II	Active
TrackX	VISION™- I SNAP	FDA UDI	Class II	Unknown
TrackX	TrackX Insight Base - NV/AT Disc Prep - MJF	FDA UDI	Class II	Unknown
TrackX	ACUITY NEEDLE - DIAMOND; 200-4TX	FDA UDI	Class II	Active
TrackX	TrackX PE ADAPT - MJF VS	FDA UDI	Class II	Active
TrackX	TrackX 1/4" Square T-Handle	FDA UDI	Class II	Active
TrackX	ACUITY NEEDLE - 15 DIAMOND - 3.2 INNER	FDA UDI	Class II	Active
TrackX	ACCESS 21-ADAPT	FDA UDI	Class II	Active
TrackX	ATEC Lateral Kit 2.0	FDA UDI	Class II	Unknown

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 3, 2024	Z-0260-2025	—	open, classified	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.
Oct 24, 2022	Z-1107-2023	—	open, classified	The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.