Home GUDID M2480120141 KGTI™ Kinetik Great Toe Implant System
Primary DI M2480120141
Brand KGTI™ Kinetik Great Toe Implant System
Company INTEGRA LIFESCIENCES CORPORATION
Model 012014
Catalog number 012014
Device description The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary canal of the phalanx. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Published 2017-10-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained Unknown U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10381780065470 Primary GS1 0 M2480120141 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780065470 10381780065470
GMDN Terms# Term, Definition table Term Definition Partial metatarsophalangeal joint prosthesis A sterile implantable artificial substitute for the distal head of the metatarsal or the adjacent phalangeal base, intended to repair an articulating surface of the metatarsophalangeal (MTP) joint of the foot (toe). The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr)] and implantation may be performed with or without bone cement. The device is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Regulatory Flags# DUNS number 963856096 Device count 1 DM exempt false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00885556828229 Movement Great Toe System Smith & Nephew, Inc. LZJ 2022-12-22 00885556828250 Movement Great Toe System Smith & Nephew, Inc. LZJ 2022-12-22 00885556828281 Movement Great Toe System Smith & Nephew, Inc. LZJ 2022-12-22 00885556828311 Movement Great Toe System Smith & Nephew, Inc. LZJ 2022-12-22 00885556828410 Movement Great Toe System Smith & Nephew, Inc. LZJ 2022-12-21 00885556828441 Movement Great Toe System Smith & Nephew, Inc. LZJ 2022-12-21 00885556828472 Movement Great Toe System Smith & Nephew, Inc. LZJ 2022-12-21 00885556828502 Movement Great Toe System Smith & Nephew, Inc. LZJ 2022-12-21 00880304216860 TOTAL TOE SYSTEM Biomet Orthopedics, LLC LZJ 2018-12-19 00880304216907 TOTAL TOE SYSTEM Biomet Orthopedics, LLC LZJ 2018-12-19 00880304216914 TOTAL TOE SYSTEM Biomet Orthopedics, LLC LZJ 2018-12-19 00880304217003 TOTAL TOE SYSTEM Biomet Orthopedics, LLC LZJ 2018-12-19 10381780065395 KGTI™ Kinetik Great Toe Implant System Ascension Orthopedics, Inc. LZJ 2017-10-09 10381780065401 KGTI™ Kinetik Great Toe Implant System Ascension Orthopedics, Inc. LZJ 2017-10-09 10381780065418 KGTI™ Kinetik Great Toe Implant System Ascension Orthopedics, Inc. LZJ 2017-10-09 10381780065425 KGTI™ Kinetik Great Toe Implant System Ascension Orthopedics, Inc. LZJ 2017-10-09 10381780065432 KGTI™ Kinetik Great Toe Implant System Ascension Orthopedics, Inc. LZJ 2017-10-09 10381780065449 KGTI™ Kinetik Great Toe Implant System Ascension Orthopedics, Inc. LZJ 2017-10-09 10381780065456 KGTI™ Kinetik Great Toe Implant System Ascension Orthopedics, Inc. LZJ 2017-10-09 10381780065463 KGTI™ Kinetik Great Toe Implant System Ascension Orthopedics, Inc. LZJ 2017-10-09 10381780065470 KGTI™ Kinetik Great Toe Implant System Ascension Orthopedics, Inc. LZJ 2017-10-09 10381780065487 KGTI™ Kinetik Great Toe Implant System Ascension Orthopedics, Inc. LZJ 2017-10-09 M2480120031 KGTI™ Kinetik Great Toe Implant System Ascension Orthopedics, Inc. LZJ 2017-10-09 M2480120101 KGTI™ Kinetik Great Toe Implant System Ascension Orthopedics, Inc. LZJ 2017-10-09 M2480120021 KGTI™ Kinetik Great Toe Implant System INTEGRA LIFESCIENCES CORPORATION LZJ 2017-10-09 M2480120041 KGTI™ Kinetik Great Toe Implant System INTEGRA LIFESCIENCES CORPORATION LZJ 2017-10-09 M2480120051 KGTI™ Kinetik Great Toe Implant System INTEGRA LIFESCIENCES CORPORATION LZJ 2017-10-09 M2480120061 KGTI™ Kinetik Great Toe Implant System INTEGRA LIFESCIENCES CORPORATION LZJ 2017-10-09 M2480120071 KGTI™ Kinetik Great Toe Implant System INTEGRA LIFESCIENCES CORPORATION LZJ 2017-10-09 M2480120121 KGTI™ Kinetik Great Toe Implant System INTEGRA LIFESCIENCES CORPORATION LZJ 2017-10-09
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