Blustone Synergy Interbody Fusion System

Intervertebral Fusion Device With Bone Graft, Cervical

Blustone Synergy, LLC

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

Pre-market Notification Details

Device IDK203520
510k NumberK203520
Device Name:Blustone Synergy Interbody Fusion System
ClassificationIntervertebral Fusion Device With Bone Graft, 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 CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-01
Decision Date2021-04-07

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