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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 K062995
Device Name M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT
Applicant
Biomet Manufacturing Corp
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact PATRICIA S BERES
Correspondent
Biomet Manufacturing Corp
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact PATRICIA S BERES
Regulation Number888.3330
Classification Product Code
KWA  
Date Received10/02/2006
Decision Date 10/31/2006
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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