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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 Uncemented Acetabular Component)
510(k) Number K050251
Device Name BALANCE HIP SYSTEM
Applicant
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581 -0587
Applicant Contact GARY BAKER
Correspondent
Biomet, Inc.
56 E. Bell Dr.
Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact GARY BAKER
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   JDL   KWY   KWZ   LPH  
LZO   LZY   MEH  
Date Received02/03/2005
Decision Date 05/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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