Home GUDID M209102160 KNEE LT 62
Primary DI M209102160
Brand KNEE LT 62
Company BIOPRO, INC.
Model 10216
Published 2015-09-16
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 JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M209102160 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Coated knee femur prosthesis A sterile implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation may be performed with or without bone cement.
Regulatory Flags# DUNS number 618749857 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M209169570 ACCU-CUT™ TWO STAGE 16957 2015-09-16 M209169580 ACCU-CUT™ TWO STAGE S 16958 2015-09-16 M209173000 ACCU-CUT™ 3mm OFFSET 17300 2015-09-16 M209173060 ACCU-CUT™ 3mm OFFSET S 17306 2015-09-16 M209175020 ACCU-CUT™ STANDARD W/2 BLADES 17502 2015-09-16 M209175030 ACCU-CUT™ 1mm OFFSET W/2 BLADES 17503 2015-09-16 M209175040 ACCU-CUT™ 2mm OFFSET W/2 BLADES 17504 2015-09-16 M209175050 ACCU-CUT™ 3mm OFFSET W/2 BLADES 17505 2015-09-16 M209175060 ACCU-CUT™ TWO STAGE W/2 BLADES 17506 2015-09-16 M209177210 ACCU-CUT™ STD MICRO CHOICE 17721 2015-09-16 M209177330 ACCU-CUT™ 1 mm MICRO CHOICE 17733 2015-09-16 M209177340 ACCU-CUT™ 2 mm MICRO CHOICE 17734 2015-09-16 M209177350 ACCU-CUT™ TWO STAGE MICRO 17735 2015-09-16 M209185780 ACCU-CUT™ 2mm W/THREADED K-WIRES 18578 2015-09-16 M209195050 ACCU-CUT™ STANDARD 19505 2015-09-16 M209195060 ACCU-CUT™ 1MM 19506 2015-09-16 M209195070 ACCU-CUT™ 2MM 19507 2015-09-16 M209195080 ACCU-CUT™ 3MM 19508 2015-09-16 M209195090 ACCU-CUT™ TWO STAGE 19509 2015-09-16 M209195100 ACCU-CUT™ LONG ARM 19510 2015-09-16
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