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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 EAST BELL DR.
WARSAW,  IN  46581 -0587
Applicant Contact ROBERT R FRIDDLE
Correspondent
BIOMET MANUFACTURING, INC.
56 EAST 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
Recalls CDRH Recalls
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