TrackX Pointer
TrackX Pointer is a Class II device made by TRACKX TECHNOLOGY Inc., cleared under FDA 510(k) K173736 on 28 Feb 2018 and listed in FDA GUDID since 26 Sep 2022 (UDI-DI 00857088008219), active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00857088008219 | Date26 Sep 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK173736 | Date28 Feb 2018 | StatusActive |
Official records
- AccessGUDID record 00857088008219
- FDA 510(k) database K173736
Across registries
- FDA 510(k) K173736 decided 28 Feb 2018 Active
- FDA GUDID UDI-DI 00857088008219 listed 26 Sep 2022 Listed
Recalls
-
- Ongoing Z-0260-2025
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.
-
- Terminated Z-1107-2023
The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.
Timeline
- Cleared FDA 510(k) K173736
- Listed FDA GUDID 00857088008219
- Recall initiated FDA recalls Z-1107-2023
- Recall initiated FDA recalls Z-0260-2025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TrackX
- Generic name
- Diagnostic x-ray digital imaging system workstation application software
- Model / reference
- Pointer
- Primary DI / UDI-DI
- 00857088008219
- 510(k) Number
- FDA product code
- OWB
- GMDN term
- Diagnostic x-ray digital imaging system workstation application software
- Device class
- Class II
- Regulation number
- 892.1650
- GUDID distribution status
- In Commercial Distribution
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