FDA.reportPublic FDA data

TrackX

Primary DI
00857088008790
Brand
TrackX
Company
TrackX Technology, LLC
Model
ACCESS-CALIBRATOR CUP 1
Catalog number
303-3TX
Device description
TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diameter of 21mm with the Calibrator 2.0.
Published
2024-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173736000TrackXTrack X Technology, LLC2018-02-28OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857088008790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857088008790008570880087908570880087900857088008790

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-787-2259support@trackx.tech

Regulatory Flags#

DUNS number
080948525
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850073646007TrackXTrackX Home Base Pin - 6mm x 100mm207-4TX2025-07-24
00850073646014TrackXTrackX Home Base Pin - 6mm x 150mm208-4TX2025-07-24
00850073646144TrackXACCESS-CALIBRATOR CUP 3 - MJF VSTX-3-45342026-05-26
00857088008684TrackXTrackX Insight Base - DS Disc Prep611-3TX2026-05-11
00850073646120TrackXTrackX AT INSERT-ADAPT 2 - MJF VSTX-3-45012026-04-08
00857088008769TrackXASC PROCEDURE KIT 1980-3TX2024-03-19
00850073646106TrackXTrackX SE RETRACT ADAPT 2-BLADE - MJF VSTX-3-44692026-02-24
00857088008813TrackXTrackX NV RETRACT-ADAPT - MJF VSTX-3-42012024-07-08
00857088008844TrackXTrackX AT INSERT-ADAPTTX-3-42622025-12-08
00857088008875TrackXTrackX SE RETRACT-ADAPT 5L - MJF VS1002-3TX2025-02-07
00857088008820TrackXTrackX AT INSERT-ADAPT - MJF VSTX-3-42292024-08-15
00850073646045TrackXTrackX NV RETRACT-ADAPT1000-3TX2025-10-24
00857088008660TrackXTrackX NV INSERT-ADAPT1001-3TX2024-09-12
00850073646052TrackXHome Base Pin Snap203-3TX2025-10-24
00850073646069TrackXInitial Dilator Snap204-3TX2025-10-24
00850073646076TrackXCobb Snap205-3TX2025-10-24
00850073646083TrackXT-Handle Snap206-3TX2025-10-24
00850073646113TrackXTrackX AWLSHIDITX-4-41552025-10-15
00850073646038TrackXTrackX Modular Malleting AdapterTX-3-43692025-05-16
00857088008653TrackXTrackX Insight Base - NV/AT Disc Prep - MJF VSTX-3-40792024-03-13

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