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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K172330
Device Name Blustone Synergy Silica System
Applicant
Blustone Synergy
5520 Ventana Ct.
Pueblo,  CO  81005
Applicant Contact Lisa Peterson
Correspondent
Kaedon Consulting, LLC
14001 Hunters Pass
Austin,  TX  78734
Correspondent Contact Lisa Peterson
Regulation Number888.3060
Classification Product Code
MQP  
Date Received08/02/2017
Decision Date 12/21/2017
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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