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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 K032072
Device Name LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE
Original Applicant
ARTHROTEK, INC.
p.o. box 587
warsaw,  IN  46581 0587
Original Contact tracy j bickel
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/03/2003
Decision Date 10/01/2003
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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