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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 K060693
Device Name MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR
Original Applicant
ARTHROTEK, INC.
56 east bell dr.
p.o. box 587
warsaw,  IN  46581 0587
Original Contact lester f padilla
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/15/2006
Decision Date 06/06/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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