trackx.techTrackX
TrackX Technology, LLC
TRACKX TECHNOLOGY Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014391847 | 3014391847 | TRACKX TECHNOLOGY Inc. | 1 | N | 2026-01-01 | 437 Dimmocks Mill Rd Ste 28 Hillsborough NC US 27278 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850073646106 | TrackX - TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument. | 1-888-787-2259 | support@trackx.tech |
| 00850073646120 | TrackX - TrackX adapter that enables physicians to more adequately utilize the REVOLVE BASE-NAVIGATOR on their surgical instrument. | 1-888-787-2259 | support@trackx.tech |
| 00850073646144 | TrackX - TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diameter of 16mm and aperture of 6mm with the Calibrator 2.0. | 1-888-787-2259 | support@trackx.tech |
| 00857088008684 | TrackX - TrackX single-use modular base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument. | 1-888-787-2259 | support@trackx.tech |
| 00857088008769 | TrackX - The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. | 1-888-787-2259 | support@trackx.tech |
| 00857088008813 | TrackX - TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument. | 1-888-787-2259 | support@trackx.tech |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 216857 | 1449290179 | K200360 | TrackX | OWB | 2020-03-05 |
| 216857 | 1119322989 | K173736 | TrackX | OWB | 2018-02-28 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| OWB | 3 | 2020-03-05 |
PMN#
GUDID#
TrackX - TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diameter of 16mm and aperture of 6mm with the Calibrator 2.0.
2026-05-26
TrackX - TrackX single-use modular base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument.
2026-05-11
TrackX - TrackX adapter that enables physicians to more adequately utilize the REVOLVE BASE-NAVIGATOR on their surgical instrument.
2026-04-08
TrackX - The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
2024-03-19
TrackX - TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument.
2026-02-24
TrackX - TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument.
2024-07-08
TrackX - TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-NV/AT DISC PREP SNAP on their surgical instrument.
2025-12-08
TrackX - TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument.
2025-02-07
TrackX - TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-NV/AT DISC PREP SNAP on their surgical instrument.
2024-08-15
TrackX - TrackX reusable adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument.
2025-10-24
TrackX - TrackX reusable adapter that enables physicians to more adequately utilize the Insight Base - NV/AT Disc Prep SNAP on their surgical instrument.
2024-09-12
TrackX - The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The Home Base Pin Snap is designed to mount onto the shaft of a cylindrical or hexagonal instrument, such as a pin.
2025-10-24
TrackX - The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The Initial Dilator Snap is designed to mount onto the shaft of a cylindrical instrument, such as an initial dilator.
2025-10-24
TrackX - The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The Cobb Snap is designed to mount onto the shaft of a surgical, disc prep instrument.
2025-10-24
TrackX - The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The T-Handle Snap is designed to mount onto the shaft of a cylindrical instrument, such as the TrackX T-Handles.
2025-10-24
TrackX - The device is a general surgical instrument: a non-sterile, reusable Jamshidi needle-like cannulated awl.
2025-10-15
TrackX - The device is a general surgical instrument: a non-sterile, single-use Pin instrument.
2025-07-24
TrackX - The device is a general surgical instrument: a non-sterile, single-use Pin instrument.
2025-07-24
TrackX - TrackX adapter that enables physicians to more adequately track INSIGHT SNAPs that are placed on instruments that undergo heavier malleting forces.
2025-05-16
TrackX - TrackX single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument.
2024-03-13
TrackX - TrackX single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument.
2024-02-15
TrackX - The device consists of a sterile Base component that mates with an Array component to create a unique SNAP that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The INSIGHT BASE-6 is designed to mount onto the shaft of a cylindrical instrument.
2020-11-04
TrackX - The device consists of a sterile Base component that mates with an Array component to create a unique SNAP that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The INSIGHT BASE-7L is designed to mount onto the shaft of a cylindrical instrument.
2021-05-28
TrackX - TrackX single-use adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument.
2024-02-08
TrackX - TrackX single-use adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument.
2023-09-06
TrackX - The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
2021-11-03
TrackX - The device consists of a sterile Screw Length Calibrator that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The Screw Length Calibrator is utilized with the TrackX VISION™-V SNAP.
2019-12-04
TrackX - Accessory device that mounts to the detector side of a 12 inch C-Arm
2018-08-29
TrackX - Accessory device that mounts to the detector side of a 9 inch C-Arm
2018-08-29
TrackX - TrackX device that consists of a non-sterile Snap component that mates with retro-reflective spheres to create a unique SNAP that enables physicians to more adequately utilize pins, such as the TrackX Hex Pins, as a Home Base.
2025-02-07
TrackX - TrackX adapter that enables physicians to more adequately utilize the INSIGHT BASE-6.5L SNAP on their surgical instrument.
2024-10-09
TrackX - Disposable snap that snaps onto a Jamshidi for the purpose of instrument tracking. Component body part # TX-3-3203
2018-10-09
TrackX - The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
2019-12-04
TrackX - Disposable snap that snaps onto a Jamshidi for instrument tracking.
2018-08-29
TrackX - The device consists of a sterile Array component that mates with an INSIGHT Base component to create a unique SNAP that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The INSIGHT™ ARRAY-ORANGE when assembled with an INSIGHT Base is designed to mount onto the shaft of a cylindrical instrument.
2020-11-04
TrackX - The device consists of a sterile Array component that mates with an INSIGHT Base component to create a unique SNAP that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The INSIGHT™ ARRAY-GREEN when assembled with an INSIGHT Base is designed to mount onto the shaft of a cylindrical instrument.
2021-05-28
TrackX - The device is a general surgical instrument: a non-sterile, reusable T-Handle instrument, with a Hudson-style quick-connect.
2024-10-09
TrackX - "The device is a general surgical instrument: a non-sterile, reusable T-Handle instrument, with a 1/4"" square-style quick-connect."
2024-10-09
TrackX - The device is a general surgical instrument: a non-sterile, reusable T-Handle instrument, with a MOD Hudson-style quick-connect.
2024-10-09
TrackX - TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diameter of 26mm with the Calibrator 2.0.
2024-09-12