Blustone Synergy Diamond SA Cervical System

Intervertebral Fusion Device With Integrated Fixation, Cervical

Blustone Synergy, LLC

The following data is part of a premarket notification filed by Blustone Synergy, Llc with the FDA for Blustone Synergy Diamond Sa Cervical System.

Pre-market Notification Details

Device IDK210382
510k NumberK210382
Device Name:Blustone Synergy Diamond SA Cervical System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant Blustone Synergy, LLC 5520 Ventana Ct Pueblo,  CO  81005
ContactTom Gentry
CorrespondentChristine Scifert
MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial,  CO  80112
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-09
Decision Date2021-07-23

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