COMPREHENSIVE PRIMARY SHOULDER STEMS

Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented

BIOMET MANUFACTURING CORP.

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

Pre-market Notification Details

Device IDK060692
510k NumberK060692
Device Name:COMPREHENSIVE PRIMARY SHOULDER STEMS
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Applicant BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
ContactSusan Alexander
CorrespondentSusan Alexander
BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw,  IN  46581 -0587
Product CodeMBF  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
Subsequent Product CodeKWT
CFR Regulation Number888.3670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-15
Decision Date2006-05-30
Summary:summary

NIH GUDID Devices

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