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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 K112237
Device Name MICROSUTURE ANCHORS
Applicant
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108 -1945
Applicant Contact COURTNEY SMITH
Correspondent
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108 -1945
Correspondent Contact COURTNEY SMITH
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
MAI   MBI  
Date Received08/04/2011
Decision Date 09/02/2011
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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