COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM

Plate, Fixation, Bone

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Comprehensiveproximal Humeral Plating System.

Pre-market Notification Details

Device IDK110320
510k NumberK110320
Device Name:COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM
ClassificationPlate, Fixation, Bone
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 CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-03
Decision Date2011-07-21
Summary:summary

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