COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY

Shoulder Prosthesis, Reverse Configuration

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Comprehensive Reverse Shoulder Humeral Tray.

Pre-market Notification Details

Device IDK113069
510k NumberK113069
Device Name:COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant BIOMET MANUFACTURING CORP. 56 BELL DRIVE Warsaw,  IN  46580
ContactPatricia S Beres
CorrespondentPatricia S Beres
BIOMET MANUFACTURING CORP. 56 BELL DRIVE Warsaw,  IN  46580
Product CodePHX  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-17
Decision Date2012-01-11
Summary:summary

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