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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 K151078
Device Name Arthrex RetroFusion Screw
Applicant
ARTHREX, INC.
1370 CREEKSIDE BOULEVARD
NAPLES,  FL  34108 -1945
Applicant Contact DAVID L ROGERS
Correspondent
ARTHREX, INC.
1370 CREEKSIDE BOULEVARD
NAPLES,  FL  34108 -1945
Correspondent Contact DAVID L ROGERS
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/22/2015
Decision Date 05/15/2015
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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