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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 K031666
Device Name ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
Applicant
ARTHREX, INC.
2885 SOUTH HORSESHOE DR.
NAPLES,  FL  34104
Applicant Contact ANN WATERHOUSE
Correspondent
ARTHREX, INC.
2885 SOUTH HORSESHOE DR.
NAPLES,  FL  34104
Correspondent Contact ANN WATERHOUSE
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
GAT  
Date Received05/29/2003
Decision Date 11/18/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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