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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K190069
Device Name SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
Applicant
Arrowhead De, LLC
328 Poplar View Ln. E., Suite 2
Collierville,  TN  38017
Applicant Contact Thomas J. Twardzik
Correspondent
Arrowhead De, LLC
328 Poplar View Ln. E., Suite 2
Collierville,  TN  38017
Correspondent Contact Patrick Mullaney
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Codes
HTY   OSN  
Date Received01/15/2019
Decision Date 05/14/2019
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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