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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 K052901
Device Name ARTHREX TENSIONLOK
Applicant
ARTHREX, INC.
1370 CREEKSIDE BLVD.
NAPLES,  FL  34108 -1945
Applicant Contact ANN WATERHOUSE
Correspondent
ARTHREX, INC.
1370 CREEKSIDE BLVD.
NAPLES,  FL  34108 -1945
Correspondent Contact ANN WATERHOUSE
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
GAT  
Date Received10/14/2005
Decision Date 12/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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