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FDA 510(k)

Binary® Anterior Cervical Plate System

K-Number: K192076 · 2019-08-29

ApplicantGenesys Spine
Decision Date2019-08-29
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Binary® Anterior Cervical Plate System is a medical device manufactured by Genesys Spine. It received FDA 510(k) clearance on 2019-08-29 under approval number K192076. 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 Binary® Anterior Cervical Plate System?

Binary® Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2019-08-29. It is manufactured by Genesys Spine. The 510(k) number is K192076.

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

Binary® Anterior Cervical Plate System received FDA 510(k) clearance on 2019-08-29, under approval number K192076.

What company makes Binary® Anterior Cervical Plate System?

Binary® Anterior Cervical Plate System is manufactured by Genesys Spine.

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

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

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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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