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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 the device name listed in this FDA 510(k) record. The listed applicant is Blustone Synergy. It received FDA 510(k) clearance on 2017-12-21 under 510(k) 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. The listed applicant is Blustone Synergy. The 510(k) number is K172330.

When did Blustone Synergy Silica System receive FDA 510(k) clearance?

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

Who is the listed applicant for Blustone Synergy Silica System?

The FDA 510(k) record lists Blustone Synergy as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Blustone Synergy as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210382Blustone Synergy Diamond SA Cervical SystemK203520Blustone Synergy Interbody Fusion System

Related Devices (Code: MQP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

Official Source

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

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