Device
TrackX single-use modular base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument.
Manufacturer
TrackX Technology, LLC
TrackX Technology, LLC
Model: TrackX Insight Base - DS Disc Prep
Catalog: 611-3TX
DI: 00857088008684
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
TrackX single-use modular base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c5c66bea-2929-4a6a-a551-31f516bbfd98
Distribution Status:
In Commercial Distribution
DUNS Number:
080948525
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00857088008684
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 58473
Name: Diagnostic x-ray digital imaging system workstation application software
Definition:
An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its intended purpose, e.g., for the rendering, visualization and manipulation of medical images to support the image display needs of clinicians, diagnosticians and technicians. A basic set of applications programs and routines are included with the multi-purpose diagnostic x-ray system workstation and can be upgraded to correct programming errors or to add new system capabilities.
FDA Product Codes
OWB
Interventional Fluoroscopic X-Ray System
Premarket Submissions
Submission Number:
K173736
Supplement Number:
000