FDA.reportPublic FDA data

TrackX

Primary DI
00857088008646
Brand
TrackX
Company
TrackX Technology, LLC
Model
TrackX Insight Base - NV/AT Disc Prep - MJF
Catalog number
TX-3-4166
Device description
TrackX single-use adapter base that enables physicians to more adequately utilize an INSIGHT-ARRAY on their surgical, disc prep instrument.
Published
2024-02-15
Public version status
Update
Distribution status
Not 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
00857088008646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857088008646008570880086468570880086460857088008646

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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Primary DI, Brand, Company table
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00190376652320CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376652337CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
00190376668307CONTOUR3DALPHATEC SPINE, INC.OWB2026-09-25
BN981BN002020Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
BN981BN00202BX101Bolt NavigationCircinus Medical Technology LLCOWB2026-09-25
00850079606081MC2 Portable X-ray SystemOXOS Medical, Inc.OWB2026-09-21
00850079606098EmitterOXOS Medical, Inc.OWB2026-09-21
00850079606104CassetteOXOS Medical, Inc.OWB2026-09-21
04547410582901FDR CROSS SlimFUJIFILM CORPORATIONOWB2026-08-14
00860014944611nView s1 with nav optionNVIEW MEDICAL INC.OWB2026-07-08
05060508110057Cydar MapsCYDAR LIMITEDOWB2026-05-27
08055186671225A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
00198715128956AngiowaveAngioWave Imaging, LLCOWB2026-05-09
08809365283033SG HealthcareSG Healthcare Co., Ltd.OWB2026-04-24
08809244060533GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060557GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060632GenorayGENORAY CO., LTD.OWB2026-04-10
00198953052488AlliaGE MEDICAL SYSTEMSOWB2025-12-17
08809244060601GenorayGENORAY CO., LTD.OWB2025-12-01
04056481145613Vascular Navigation PADBrainlab SEOWB2025-09-11
04056869993973LUMINOS Q.namix RSiemens Healthcare GmbHOWB2025-07-30
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00850073646007TrackXTrackX Technology, LLCOWB2025-07-24