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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 K012872
Device Name RESORBABLE SCREW ANCHOR
Original Applicant
ARTHROTEK, INC.
56 east belle dr.
p.o. box 587
warsaw,  IN  46582
Original Contact sara b shultz
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/27/2001
Decision Date 11/20/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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