Distal Centralizers

Prosthesis, Hip, Femoral Component, Cemented, Metal

Biomet Inc.

The following data is part of a premarket notification filed by Biomet Inc. with the FDA for Distal Centralizers.

Pre-market Notification Details

Device IDK193546
510k NumberK193546
Device Name:Distal Centralizers
ClassificationProsthesis, Hip, Femoral Component, Cemented, Metal
Applicant Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw,  IN  46581
ContactJessica Andreshak
CorrespondentRhonda Myer
Biomet Inc. 56 East Bell Drive, PO Box 587 Warsaw,  IN  46581
Product CodeJDG  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-20
Decision Date2020-09-25

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