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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bone cement
510(k) Number K091608
Device Name COBALT MV BONE CEMENT
Applicant
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact SUSAN ALEXANDER
Correspondent
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact SUSAN ALEXANDER
Regulation Number888.3027
Classification Product Code
LOD  
Date Received06/03/2009
Decision Date 09/17/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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