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FDA 510(k)

ASSURE® Anterior Cervical Plate System

K-Number: K183056 · 2019-04-19

ApplicantGlobus Medical, Inc.
Decision Date2019-04-19
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASSURE® Anterior Cervical Plate System is a medical device manufactured by Globus Medical, Inc.. It received FDA 510(k) clearance on 2019-04-19 under approval number K183056. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASSURE® Anterior Cervical Plate System?

ASSURE® Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2019-04-19. It is manufactured by Globus Medical, Inc.. The 510(k) number is K183056.

When was ASSURE® Anterior Cervical Plate System approved by the FDA?

ASSURE® Anterior Cervical Plate System received FDA 510(k) clearance on 2019-04-19, under approval number K183056.

What company makes ASSURE® Anterior Cervical Plate System?

ASSURE® Anterior Cervical Plate System is manufactured by Globus Medical, Inc..

What is the FDA product code for ASSURE® Anterior Cervical Plate System?

The FDA product code for ASSURE® Anterior Cervical Plate System is KWQ.

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Other Devices by Globus Medical, Inc.

K161379ELSA Spacers K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments K160597INDEPENDENCE MIS Spacers K161223TransContinental® M Spacers and InterContinental® Plate-Spacers K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer K151665SUSTAIN Additional Implants

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Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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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