Home GUDID M209103020 UNI LM/RL LG
Primary DI M209103020
Brand UNI LM/RL LG
Company BIOPRO, INC.
Model 10302
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 HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M209103020 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Coated unicondylar knee femur prosthesis A sterile implantable device designed to replace the bearing surface of one femoral condyle (femoral component) during primary or revision unicompartmental replacement of the knee joint. 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 articulates with a tibial component and an insert, 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
Other Devices Sharing Product Codes#