FDA.reportPublic FDA data

Linkt

Primary DI
00810146163916
Brand
Linkt
Company
TRAX SURGICAL INC.
Model
SK09
Catalog number
SK09
Device description
Linkt Staple Instrument Kit - 9mm
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
00810146163916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810146163916008101461639168101461639160810146163916

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
00810146164340Redifix72422724222026-07-20
00810146164357Redifix72425724252026-07-20
00810146164388Redifix72428724282026-07-20
00810146164418Redifix72431724312026-07-20
00810146164449Redifix72434724342026-07-20
00810146164456Redifix72435724352026-07-20
00810146164463Redifix72436724362026-07-20
00810146164500Redifix72440724402026-07-20
00810146164517Redifix72441724412026-07-20
00810146164531Redifix72443724432026-07-20
00810146164562Redifix72446724462026-07-20
00810146164579Redifix72447724472026-07-20
00810146164623Redifix72452724522026-07-20
00810146164654Redifix72455724552026-07-20
00810146164685Redifix72458724582026-07-20
00810146164692Redifix72459724592026-07-20
00810146164715Redifix72462724622026-07-20
00810146160106Trax SurgicalACC-LACC-L2025-06-30
00810146160113Trax SurgicalACC-MACC-M2025-06-30
00810146160120Trax SurgicalACC-SACC-S2025-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956400795CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956464988CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956506732CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956514874CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956519756CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956533622CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956535459CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956535688CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956548305CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956548695CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956549722CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956549975CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956550780CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956550902CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956551374CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956557741CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956561984CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956565937CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956567894CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956568488CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956571242CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956580084CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956581357CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956582354CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956583955CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956584730CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956584938CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956586314CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956588172CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19
10198956591301CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-19