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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 K041274
Device Name RESORBABLE INTERFERENCE SCREW
Original Applicant
ARTHROTEK, INC.
p.o. box 587
warsaw,  IN  46581 0587
Original Contact gary baker
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/12/2004
Decision Date 07/28/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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