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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 K103755
Device Name TAPERLOC COMPLETE, SIZE 5 AND 6
Applicant
Biomet Manufacturing Corp
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact BECKY EARL
Correspondent
Biomet Manufacturing Corp
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact BECKY EARL
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   JDL   KWL   KWY   KWZ  
LPH   LWJ   LZO   MAY   MEH  
Date Received12/23/2010
Decision Date 01/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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