G7 Freedom And Offset Liners, Freedom Head, Size 32

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

Biomet, Inc.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for G7 Freedom And Offset Liners, Freedom Head, Size 32.

Pre-market Notification Details

Device IDK142882
510k NumberK142882
Device Name:G7 Freedom And Offset Liners, Freedom Head, Size 32
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant Biomet, Inc. 56 East Bell Drive Warsaw,  IN  46581
ContactBecky Earl
CorrespondentBecky Earl
Biomet, Inc. 56 East Bell Drive Warsaw,  IN  46581
Product CodeLPH  
Subsequent Product CodeJDI
Subsequent Product CodeKWZ
Subsequent Product CodeLZO
Subsequent Product CodeOQG
Subsequent Product CodeOQH
Subsequent Product CodeOQI
Subsequent Product CodePBI
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-02
Decision Date2015-02-10
Summary:summary

NIH GUDID Devices

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