Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Blustone Synergy Silica System

K-Number: K172330 · 2017-12-21

ApplicantBlustone Synergy
Decision Date2017-12-21
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Blustone Synergy Silica System is a medical device manufactured by Blustone Synergy. It received FDA 510(k) clearance on 2017-12-21 under approval number K172330. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Blustone Synergy Silica System?

Blustone Synergy Silica System is a medical device that received FDA 510(k) clearance on 2017-12-21. It is manufactured by Blustone Synergy. The 510(k) number is K172330.

When was Blustone Synergy Silica System approved by the FDA?

Blustone Synergy Silica System received FDA 510(k) clearance on 2017-12-21, under approval number K172330.

What company makes Blustone Synergy Silica System?

Blustone Synergy Silica System is manufactured by Blustone Synergy.

What is the FDA product code for Blustone Synergy Silica System?

The FDA product code for Blustone Synergy Silica System is MQP.

Related Clinical Trials

NCT03736226 A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China ACTIVE_NOT_RECRUITING NCT05305430 Real World Data Collection on the Synergy Cervical Disc RECRUITING NCT05880823 Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc WITHDRAWN NCT06383962 Post-Market Data Collection to Evaluate the Performance of the Synergy Disc® RECRUITING NCT06465862 Development of a Silica Microparticle Taggant System to Measure ART Adherence WITHDRAWN NCT05417893 Non-inferiority Clinical Trial to Compare the Safety and Performance of MeRes100 Sirolimus-eluting BioResorbable Vascular Scaffold System Versus Contemporary DES Platforms in Patients With de Novo Coronary Artery Lesions WITHDRAWN

Related Devices (Code: MQP)

K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc. K172323Omnia Medical VBROmnia Medical, LLC K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine K171704CAPRI Corpectomy Cage SystemK2m K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑