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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K142882
Device Name G7 Freedom and Offset Liners, Freedom Head, Size 32
Applicant
Biomet, Inc.
56 East Bell Drive
Warsaw,  IN  46581
Applicant Contact Becky Earl
Correspondent
Biomet, Inc.
56 East Bell Drive
Warsaw,  IN  46581
Correspondent Contact Becky Earl
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWZ   LZO   OQG   OQH  
OQI   PBI  
Date Received10/02/2014
Decision Date 02/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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