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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K180324
Device Name Patriot Spinal Fixation System
Applicant
Valorus Spine
822 Hartz Way, Suite 230
Danville,  CA  94526
Applicant Contact Leah Fero
Correspondent
Watershed Idea Foundry
1815 Aston Ave., Suite 106
Carlsbad,  CA  92008
Correspondent Contact Nicholas M. Cordaro
Regulation Number888.3070
Classification Product Code
NKB  
Date Received02/05/2018
Decision Date 04/06/2018
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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