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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K032187
Device Name ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM
Original Applicant
ARTHREX, INC.
2885 south horseshoe dr.
naples,  FL  34104
Original Contact sally foust
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received07/22/2003
Decision Date 09/22/2003
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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