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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 K040475
Device Name MICROMAX SUTURE ANCHOR
Applicant
BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact KACY ARNOLD
Correspondent
BIOMET, INC.
56 EAST BELL DR.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact KACY ARNOLD
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/24/2004
Decision Date 05/21/2004
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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