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TRACKX TECHNOLOGY Inc.

US

Last updated September 17, 2026

Information

Country
US
Address
437 Dimmocks Mill Rd Ste 28, Hillsborough, NC, 27278
Website
—
LinkedIn
—
Facebook
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Email
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Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3014391847
DUNS Number
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Catalogue (77)

Page 2 of 2
DeviceModel / ReferenceRegistriesClassStatus
TrackX TrackX Insight Base - DS Disc Prep - MJF VS
FDA UDI
Class IIActive
TrackX REVOLVE BASE-NAVIGATOR
FDA UDI
Class IIActive
TrackX ASC PROCEDURE KIT 1
FDA UDI
Class IIActive
TrackX Hex Pin 6mm x 100mm
FDA UDI
Class IIActive
TrackX Snap 11
FDA UDI
Class IIUnknown
TrackX TrackX PE ADAPT
FDA UDI
Class IIActive
TrackX HANG-TEN SNAP
FDA UDI
Class IIUnknown
TrackX INSIGHT™-6 SNAP
FDA UDI
Class IIActive
TrackX INSIGHT™ BASE FLEX-8
FDA UDI
Class IIActive
TrackX TrackX 1/4" EXT-ADAPT
FDA UDI
Class IIActive
TrackX 21 cm Flat Panel Collar Assembly
FDA UDI
Class IIActive
TrackX TrackX Modular Malleting Adapter
FDA UDI
Class IIActive
TrackX TrackX NV RETRACT-ADAPT
FDA UDI
Class IIUnknown
TrackX TrackX Insight Base - NV/AT Disc Prep
FDA UDI
Class IIActive
TrackX INSIGHT™ ARRAY-GREEN
FDA UDI
Class IIActive
TrackX INSIGHT™ BASE-2L
FDA UDI
Class IIActive
TrackX INSIGHT™ ARRAY-AQUA
FDA UDI
Class IIActive
TrackX ACCESS-LR1 SNAP
FDA UDI
Class IIActive
TrackX 9 inch Source Cap Original Assembly
FDA UDI
Class IIActive
TrackX 9 inch C-Arm Collar Assembly
FDA UDI
Class IIUnknown
TrackX 12 inch Source Cap Original Assembly
FDA UDI
Class IIActive
TrackX INSIGHT™ BASE-6
FDA UDI
Class IIUnknown
TrackX INSIGHT™ BASE-6.5L
FDA UDI
Class IIActive
TrackX T SNAP
FDA UDI
Class IIUnknown
TrackX TrackX SE RETRACT-ADAPT 6.5L - MJF VS
FDA UDI
Class IIUnknown
TrackX K200360
FDA 510(k)
Class IIActive
TrackX K173736
FDA 510(k)
Class IIActive

Related Companies

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No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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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.

DateRecall No.ClassStatusReason
Sep 3, 2024Z-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, 2022Z-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.