REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

BIOMET MANUFACTURING, INC.

The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Repicci Ii Onlay Unicompartmental Tibial Component.

Pre-market Notification Details

Device IDK053299
510k NumberK053299
Device Name:REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT
ClassificationProsthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Applicant BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw,  IN  46581 -0587
ContactPatricia S Beres
CorrespondentPatricia S Beres
BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw,  IN  46581 -0587
Product CodeHRY  
CFR Regulation Number888.3530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-11-25
Decision Date2006-01-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00880304446960 K053299 000

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