MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD

Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Mosaic Non-modular Proximal Body And Eas Offset Modular Humeral Head.

Pre-market Notification Details

Device IDK042321
510k NumberK042321
Device Name:MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD
ClassificationProsthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw,  IN  46581 -0587
ContactKacy Arnold
CorrespondentKacy Arnold
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw,  IN  46581 -0587
Product CodeKWT  
CFR Regulation Number888.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-26
Decision Date2005-01-28
Summary:summary

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