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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K080088
Device Name BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS
Applicant
Biomet Manufacturing, Inc.
56 E Bell Dr.
Warsaw,  IN  46581 -0587
Applicant Contact ROBERT R FRIDDLE
Correspondent
Biomet Manufacturing, Inc.
56 E Bell Dr.
Warsaw,  IN  46581 -0587
Correspondent Contact ROBERT R FRIDDLE
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
JDR   MAI   MBI  
Date Received01/14/2008
Decision Date 06/11/2008
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
Recalls CDRH Recalls
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