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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 the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2019-11-08 under 510(k) 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. The listed applicant is Innovasis, Inc.. The 510(k) number is K192049.

When did Oryx Cervical Plate System receive FDA 510(k) clearance?

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

Who is the listed applicant for Oryx Cervical Plate System?

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

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

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

Other records listing Innovasis, Inc. 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.

K250076Endeavor™ Stand-Alone Cervical IBF SystemK251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)K250603AxTiHA® Stand-Alone ALIF SystemK250182Innovasis Navigation InstrumentsK241276Vector™ Pedicle Screw SystemK231899HAtetracell™-C Titanium Cervical IBF System

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Related Devices (Code: KWQ)

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.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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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