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FDA 510(k)

Oryx Cervical Plate System

K-Number: K192049 · 2019-11-08

ApplicantInnovasis, Inc.
Decision Date2019-11-08
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Oryx Cervical Plate System is a medical device manufactured by Innovasis, Inc.. It received FDA 510(k) clearance on 2019-11-08 under approval number K192049. 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 Oryx Cervical Plate System?

Oryx Cervical Plate System is a medical device that received FDA 510(k) clearance on 2019-11-08. It is manufactured by Innovasis, Inc.. The 510(k) number is K192049.

When was Oryx Cervical Plate System approved by the FDA?

Oryx Cervical Plate System received FDA 510(k) clearance on 2019-11-08, under approval number K192049.

What company makes Oryx Cervical Plate System?

Oryx Cervical Plate System is manufactured by Innovasis, Inc..

What is the FDA product code for Oryx Cervical Plate System?

The FDA product code for Oryx Cervical Plate System is KWQ.

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Other Devices by Innovasis, Inc.

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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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