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FDA 510(k)

Blustone Synergy Diamond SA Cervical System

K-Number: K210382 · 2021-07-23

ApplicantBlustone Synergy, LLC
Decision Date2021-07-23
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Blustone Synergy Diamond SA Cervical System is a medical device manufactured by Blustone Synergy, LLC. It received FDA 510(k) clearance on 2021-07-23 under approval number K210382. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Blustone Synergy Diamond SA Cervical System?

Blustone Synergy Diamond SA Cervical System is a medical device that received FDA 510(k) clearance on 2021-07-23. It is manufactured by Blustone Synergy, LLC. The 510(k) number is K210382.

When was Blustone Synergy Diamond SA Cervical System approved by the FDA?

Blustone Synergy Diamond SA Cervical System received FDA 510(k) clearance on 2021-07-23, under approval number K210382.

What company makes Blustone Synergy Diamond SA Cervical System?

Blustone Synergy Diamond SA Cervical System is manufactured by Blustone Synergy, LLC.

What is the FDA product code for Blustone Synergy Diamond SA Cervical System?

The FDA product code for Blustone Synergy Diamond SA Cervical System is OVE.

Related Clinical Trials

NCT03736226 A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China ACTIVE_NOT_RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07153536 Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis 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Disc RECRUITING NCT05880823 Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc WITHDRAWN

Other Devices by Blustone Synergy, LLC

K203520Blustone Synergy Interbody Fusion System

Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, 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.

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