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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 K061665
Device Name ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT
Applicant
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108
Applicant Contact ANN WATERHOUSE
Correspondent
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108
Correspondent Contact ANN WATERHOUSE
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received06/14/2006
Decision Date 07/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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