Home GUDID M209103010 UNI LM/RL MD
Primary DI M209103010
Brand UNI LM/RL MD
Company BIOPRO, INC.
Model 10301
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 M209103010 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 M209232580 Hintermann Compressor 23258 2026-05-22 M209232590 Hintermann Distractor 23259 2026-05-22 M209186080 10mm HBS® Standard Compression 18608 2015-09-16 M209186090 11mm HBS® Standard Compression 18609 2015-09-16 M209186100 12mm HBS® Standard Compression 18610 2015-09-16 M209186110 13mm HBS® Standard Compression 18611 2015-09-16 M209186120 14mm HBS® Standard Compression 18612 2015-09-16 M209186130 15mm HBS® Standard Compression 18613 2015-09-16 M209186140 16mm HBS® Standard Compression 18614 2015-09-16 M209186150 17mm HBS® Standard Compression 18615 2015-09-16 M209186160 18mm HBS® Standard Compression 18616 2015-09-16 M209186170 19mm HBS® Standard Compression 18617 2015-09-16 M209186180 20mm HBS® Standard Compression 18618 2015-09-16 M209186190 21mm HBS® Standard Compression 18619 2015-09-16 M209186200 22mm HBS® Standard Compression 18620 2015-09-16 M209186210 23mm HBS® Standard Compression 18621 2015-09-16 M209186220 24mm HBS® Standard Compression 18622 2015-09-16 M209186230 25mm HBS® Standard Compression 18623 2015-09-16 M209186240 26mm HBS® Standard Compression 18624 2015-09-16 M209186250 27mm HBS® Standard Compression 18625 2015-09-16
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