MAK OSS KNEE FEMORAL COMPONENTS

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Mak Oss Knee Femoral Components.

Pre-market Notification Details

Device IDK083779
510k NumberK083779
Device Name:MAK OSS KNEE FEMORAL COMPONENTS
ClassificationProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactPatricia S Beres
CorrespondentPatricia S Beres
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeKRO  
CFR Regulation Number888.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-19
Decision Date2009-04-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304654105 K083779 000
00880304653955 K083779 000
00880304653948 K083779 000
00880304653931 K083779 000
00880304653924 K083779 000
00880304653917 K083779 000
00880304653900 K083779 000
00880304653894 K083779 000
00880304653887 K083779 000
00880304653870 K083779 000
00880304653863 K083779 000
00880304653856 K083779 000
00880304653962 K083779 000
00880304653979 K083779 000
00880304653986 K083779 000
00880304654099 K083779 000
00880304654082 K083779 000
00880304654075 K083779 000
00880304654068 K083779 000
00880304654051 K083779 000
00880304654044 K083779 000
00880304654037 K083779 000
00880304654020 K083779 000
00880304654013 K083779 000
00880304654006 K083779 000
00880304653993 K083779 000
00880304653283 K083779 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.