Home GUDID M5289P0710020
HemiCAP®
Primary DI M5289P0710020
Brand HemiCAP®
Company ARTHROSURFACE INCORPORATED
Model 9P07-1002
Catalog number 9P07-1002
Device description 1.5mm Pin Kit, ToeMOTION
Published 2016-07-14
Public version status Update
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 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 M5289P0710020 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone wire A wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 1.5 Millimeter
Regulatory Flags# DUNS number 144666109 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true 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