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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 K171407
Device Name ExsoMed ArcPhix and ExsoMed ArrowPhix
Applicant
Exsomed Holding Company, LLC
7227 N 16th St., Suite 245
Phoenix,  AZ  85020
Applicant Contact Richard L. Kovach
Correspondent
Exsomed Holding Company, LLC
7227 N 16th St., Suite 245
Phoenix,  AZ  85020
Correspondent Contact Richard L. Kovach
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/12/2017
Decision Date 08/18/2017
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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