Blustone Synergy Silica System

Spinal Vertebral Body Replacement Device

Blustone Synergy

The following data is part of a premarket notification filed by Blustone Synergy with the FDA for Blustone Synergy Silica System.

Pre-market Notification Details

Device IDK172330
510k NumberK172330
Device Name:Blustone Synergy Silica System
ClassificationSpinal Vertebral Body Replacement Device
Applicant Blustone Synergy 5520 Ventana Ct. Pueblo,  CO  81005
ContactLisa Peterson
CorrespondentLisa Peterson
Kaedon Consulting LLC 14001 Hunters Pass Austin,  TX  78734
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-02
Decision Date2017-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00810482030088 K172330 000

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