Home GUDID M209141460 TRAY UNI COMP SM
Primary DI M209141460
Brand TRAY UNI COMP SM
Company BIOPRO, INC.
Model 14146
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 M209141460 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Unicondylar knee prosthesis A sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee.
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#