TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS

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 Titanium Versa-dial Humeral Head Prosthesis.

Pre-market Notification Details

Device IDK140390
510k NumberK140390
Device Name:TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactBrian Kincaid
CorrespondentBrian Kincaid
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. 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 Received2014-02-14
Decision Date2014-09-10
Summary:summary

NIH GUDID Devices

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