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FDA 510(k)

Aurora® Anterior Lumbar Plate Sytstem

K-Number: K201079 · 2020-08-05

ApplicantPrism Surgical Design Pty , Ltd.
Decision Date2020-08-05
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Aurora® Anterior Lumbar Plate Sytstem is the device name listed in this FDA 510(k) record. The listed applicant is Prism Surgical Design Pty , Ltd.. It received FDA 510(k) clearance on 2020-08-05 under 510(k) number K201079. 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 Aurora® Anterior Lumbar Plate Sytstem?

Aurora® Anterior Lumbar Plate Sytstem is a medical device that received FDA 510(k) clearance on 2020-08-05. The listed applicant is Prism Surgical Design Pty , Ltd.. The 510(k) number is K201079.

When did Aurora® Anterior Lumbar Plate Sytstem receive FDA 510(k) clearance?

Aurora® Anterior Lumbar Plate Sytstem received FDA 510(k) clearance on 2020-08-05, under 510(k) number K201079.

Who is the listed applicant for Aurora® Anterior Lumbar Plate Sytstem?

The FDA 510(k) record lists Prism Surgical Design Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aurora® Anterior Lumbar Plate Sytstem?

The FDA product code for Aurora® Anterior Lumbar Plate Sytstem is KWQ.

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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