FDA.reportPublic FDA data

Linkt

Primary DI
00810146163930
Brand
Linkt
Company
TRAX SURGICAL INC.
Model
SK15
Catalog number
SK15
Device description
Linkt Staple Instrument Kit - 15mm
Published
2025-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810146163930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810146163930008101461639308101461639300810146163930

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119400763
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810146160106Trax SurgicalACC-LACC-L2025-06-30
00810146160113Trax SurgicalACC-MACC-M2025-06-30
00810146160120Trax SurgicalACC-SACC-S2025-06-30
00810146163916LinktSK09SK092025-06-30
00810146163923LinktSK12SK122025-06-30
00810146163947LinktSK18SK182025-06-30
00810146163954LinktSK20SK202025-06-30
00810146164197LinktSTP0909STP09092025-06-30
00810146164210LinktSTP1212STP12122025-06-30
00810146164234LinktSTP1515STP15152025-06-30
00810146164258LinktSTP1818STP18182025-06-30
00810146164272LinktSTP2020STP20202025-06-30
00810146164296LinktSTP1814STP18142025-06-30
00810146164876Trax SurgicalACC-S2-HDACC-S2-HD2025-06-30
00810146164883Trax SurgicalACC-S2-HLACC-S2-HL2025-06-30
00810146164890LinktSTP1512STP15122025-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956440326CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
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10198956460720CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
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10198956482005CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956482166CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956482425CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956483279CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
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10198956483835CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956484719CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
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10198956484887CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956487192CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956488175CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08