FDA.reportPublic FDA data

Linkt

Primary DI
00810146164258
Brand
Linkt
Company
TRAX SURGICAL INC.
Model
STP1818
Catalog number
STP1818
Device description
Linkt Compression Staple - 18mm x 18mm
Published
2025-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDRStaple, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250712000Linkt Compression Staple SystemTrax Surgical2025-05-14JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810146164258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810146164258008101461642588101461642580810146164258

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustableA non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119400763
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00810146163930LinktSK15SK152025-06-30
00810146163947LinktSK18SK182025-06-30
00810146163954LinktSK20SK202025-06-30
00810146164197LinktSTP0909STP09092025-06-30
00810146164210LinktSTP1212STP12122025-06-30
00810146164234LinktSTP1515STP15152025-06-30
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
05060267134523Fastlok 8mm x 23mmXIROS LTDJDR2026-02-16
05060267134530Fastlok 6mm x 23mmXIROS LTDJDR2026-02-16
10193489020892MEDLINEMEDLINE INDUSTRIES, INC.JDR2026-02-10
10193489020915MEDLINEMEDLINE INDUSTRIES, INC.JDR2026-02-10
10193489020946MEDLINEMEDLINE INDUSTRIES, INC.JDR2026-02-10
00810111225236Lapiplasty SpeedPlate - TMTTreace Medical Concepts, Inc.JDR2026-01-23
00810135964180VertexNVISION BIOMEDICAL TECHNOLOGIES, INC.JDR2025-12-17
00810111224918TMC FastPitch ScrewsTreace Medical Concepts, Inc.JDR2025-12-12
00810111225175TMC SpeedTMTTreace Medical Concepts, Inc.JDR2025-12-12
00810111225199TMC SpeedTMTTreace Medical Concepts, Inc.JDR2025-12-12
00810111225373TMC SpeedTMTTreace Medical Concepts, Inc.JDR2025-12-12
00810111224857TMC SpeedMTPTreace Medical Concepts, Inc.JDR2025-11-14
00860005968824RELJA Innovations Nitinol Staple Kit 15mmx12mmRelja Innovations LLCJDR2025-09-19
00860005968831RELJA Innovations Nitinol Staple Kit 18x18Relja Innovations LLCJDR2025-09-19
00854325007004Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007011Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007028Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007035Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007042Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007059Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007066Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007073Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007080Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007097Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007103Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007110Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007127Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007134Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007141Reign MedicalF & A Foundation LLCJDR2025-09-05
00854325007158Reign MedicalF & A Foundation LLCJDR2025-09-05