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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K203520
Device Name Blustone Synergy Interbody Fusion System
Applicant
Blustone Synergy, LLC
5520 Ventana Ct.
Pueblo,  CO  81005
Applicant Contact Tom Gentry
Correspondent
MRC Global, LLC
9085 E. Mineral Cir., Suite 110
Centennial,,  CO  80112
Correspondent Contact Christine Scifert
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received12/01/2020
Decision Date 04/07/2021
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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