100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

BIOMET MANUFACTURING, INC.

The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for 100kgy E-poly Acetabular Liners-additional Profiles.

Pre-market Notification Details

Device IDK070399
510k NumberK070399
Device Name:100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw,  IN  46581 -0578
ContactTracy B Johnson
CorrespondentTracy B Johnson
BIOMET MANUFACTURING, INC. P.O. BOX 587 Warsaw,  IN  46581 -0578
Product CodeJDI  
Subsequent Product CodeLPH
Subsequent Product CodeLWJ
Subsequent Product CodeMAY
Subsequent Product CodeOQG
Subsequent Product CodeOQH
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-12
Decision Date2007-05-04
Summary:summary

NIH GUDID Devices

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