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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K991971
Device Name ARTHREX CHONDRAL DART, MODEL AR-4005B-18
Applicant
Arthrex, Inc.
2885 S. Horseshoe Dr.
Naples,  FL  34104
Applicant Contact VERNON C BROWN
Correspondent
Arthrex, Inc.
2885 S. Horseshoe Dr.
Naples,  FL  34104
Correspondent Contact VERNON C BROWN
Regulation Number888.3040
Classification Product Code
HTY  
Date Received06/11/1999
Decision Date 08/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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