FDA.report

TrackX

Primary DI
00850073646144
Brand
TrackX
Company
TrackX Technology, LLC
Model
ACCESS-CALIBRATOR CUP 3 - MJF VS
Catalog number
TX-3-4534
Device description
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.
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications

CodeDeviceSpecialtyClass
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions

SubmissionSupplement
K173736000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K173736000TrackXTrack X Technology, LLC2018-02-28OWB

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850073646144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850073646144008500736461448500736461440850073646144

GMDN Terms

TermDefinition
Diagnostic x-ray digital imaging system workstation application softwareAn 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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-888-787-2259support@trackx.tech

Regulatory Flags

DUNS number
080948525
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00857088008844TrackXTrackX AT INSERT-ADAPTTX-3-42622025-12-08
00850073646007TrackXTrackX Home Base Pin - 6mm x 100mm207-4TX2025-07-24
00850073646014TrackXTrackX Home Base Pin - 6mm x 150mm208-4TX2025-07-24
00850073646038TrackXTrackX Modular Malleting AdapterTX-3-43692025-05-16
00857088008875TrackXTrackX SE RETRACT-ADAPT 5L - MJF VSTX-3-43002025-02-07
00857088008943TrackXTrackX HOME BASE VS SNAPTX-3-43142025-02-07
00857088008271TrackXINSIGHT™ ARRAY-ORANGE702-3TX2020-11-04
00857088008288TrackXINSIGHT™ BASE-6600-3TX2020-11-04
00857088008332TrackXINSIGHT™ BASE-7L601-3TX2021-05-28
00857088008349TrackXINSIGHT™ ARRAY-GREEN701-3TX2021-05-28
00857088008752TrackXTrackX Hudson T-Handle1003-3TX2024-10-09
00857088008776TrackXTrackX 1/4" Square T-Handle1004-3TX2024-10-09
00857088008783TrackXTrackX Hudson MOD T-Handle1005-3TX2024-10-09
00857088008851TrackXTrackX SE RETRACT-ADAPT 6.5L - MJF VSTX-3-42732024-10-09
00857088008660TrackXTrackX NV INSERT-ADAPTTX-3-40892024-09-12
00857088008745TrackXACCESS-CALIBRATOR CUP 2304-3TX2024-09-12
00857088008806TrackXTrackX Insight Base - NV/AT Disc Prep610-3TX2024-09-12
00857088008790TrackXACCESS-CALIBRATOR CUP 1303-3TX2024-08-15
00857088008820TrackXTrackX AT INSERT-ADAPT - MJF VSTX-3-42292024-08-15
00857088008813TrackXTrackX NV RETRACT-ADAPT - MJF VSTX-3-42012024-07-08

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