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 | |
|---|---|---|---|
| 00850073646007 | TrackX - The device is a general surgical instrument: a non-sterile, single-use Pin instrument. | 1-888-787-2259 | support@trackx.tech |
| 00850073646014 | TrackX - The device is a general surgical instrument: a non-sterile, single-use Pin instrument. | 1-888-787-2259 | support@trackx.tech |
| 00850073646038 | TrackX - TrackX adapter that enables physicians to more adequately track INSIGHT SNAPs that are placed on instruments that undergo heavier malleting forces. | 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 adapter that enables physicians to more adequately utilize the INSIGHT BASE-NV/AT DISC PREP SNAP on their surgical instrument.
2025-12-08
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 adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument.
2025-02-07
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 - 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 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 - 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 adapter that enables physicians to more adequately utilize the INSIGHT BASE-6.5L SNAP on their surgical instrument.
2024-10-09
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 - TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diameter of 26mm with the Calibrator 2.0.
2024-09-12
TrackX - TrackX single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument.
2024-09-12
TrackX - TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diameter of 21mm with the Calibrator 2.0.
2024-08-15
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 adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument.
2024-07-08
TrackX - TrackX single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument.
2024-06-13
TrackX - The device is a general surgical instrument: a non-sterile, reusable Pin instrument.
2024-05-28
TrackX - The device is a general surgical instrument: a non-sterile, reusable Pin instrument.
2024-05-28
TrackX - The device is a general surgical instrument: a sterilized, disposable, single use jamshidi like needle.
2024-05-28
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-VIOLET when assembled with an INSIGHT Base is designed to mount onto the shaft of a cylindrical instrument.
2024-04-30
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 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 - TrackX single-use adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument.
2024-02-08
TrackX - The device is a general surgical instrument: a non-sterile, reusable Dilator instrument.
2023-12-15
TrackX - TrackX reusable adapter that enables physicians to more adequately utilize the INSIGHT BASE FLEX-25 SNAP on their surgical instrument.
2023-12-13
TrackX - TrackX reusable adapter that enables physicians to more adequately utilize the INSIGHT REVOLVE-BASE NAVIGATOR SNAP on their surgical instruments with the 1/4" quick connect feature.
2023-10-30
TrackX - Accessory device that mounts to the detector side of a 31cm GE OEC Elite CFD.
2023-09-06
TrackX - Accessory device that mounts to the source side of a 31cm GE OEC Elite CFD.
2023-09-06
TrackX - Accessory device that mounts to the detector side of a 21cm GE OEC Elite CFD.
2023-09-06
TrackX - Accessory device that mounts to the source side of a 21cm GE OEC Elite CFD.
2023-09-06
TrackX - TrackX reusable adapter that enables physicians to more adequately utilize the INSIGHT REVOLVE-BASE NAVIGATOR SNAP on their surgical instrument.
2023-09-06
TrackX - TrackX single-use adapter that enables physicians to more adequately utilize the INSIGHT REVOLVE-BASE NAVIGATOR SNAP on their surgical instrument.
2023-09-06
TrackX - TrackX single-use adapter that enables physicians to more adequately utilize the INSIGHT BASE-5L SNAP on their surgical instrument.
2023-09-06