MEDALLION MODULAR HIP SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

BIOMET MANUFACTURING, INC.

The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Medallion Modular Hip System.

Pre-market Notification Details

Device IDK041850
510k NumberK041850
Device Name:MEDALLION MODULAR HIP SYSTEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw,  IN  46581 -0578
ContactLonnie Witham
CorrespondentLonnie Witham
BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw,  IN  46581 -0578
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-08
Decision Date2004-12-21
Summary:summary

NIH GUDID Devices

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