COMPREHENSIVE CONVERTIBLE GLENOID

Shoulder Prosthesis, Reverse Configuration

BIOMET MANUFACTURING, INC.

The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Comprehensive Convertible Glenoid.

Pre-market Notification Details

Device IDK130390
510k NumberK130390
Device Name:COMPREHENSIVE CONVERTIBLE GLENOID
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw,  IN  46580 -0587
ContactPatricia Sandborn Beres
CorrespondentPatricia Sandborn Beres
BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw,  IN  46580 -0587
Product CodePHX  
Subsequent Product CodeKWS
Subsequent Product CodeKWT
Subsequent Product CodeMBF
Subsequent Product CodePAO
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-02-15
Decision Date2013-10-09
Summary:summary

NIH GUDID Devices

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