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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 K143614
Device Name Arthrex Low Profile Screws
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  
Subsequent Product Code
HRS  
Date Received12/19/2014
Decision Date 01/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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