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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 a medical device manufactured by Prism Surgical Design Pty , Ltd.. It received FDA 510(k) clearance on 2020-08-05 under approval 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. It is manufactured by Prism Surgical Design Pty , Ltd.. The 510(k) number is K201079.

When was Aurora® Anterior Lumbar Plate Sytstem approved by the FDA?

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

What company makes Aurora® Anterior Lumbar Plate Sytstem?

Aurora® Anterior Lumbar Plate Sytstem is manufactured by Prism Surgical Design Pty , Ltd..

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 Clinical Trials

NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related Devices (Code: KWQ)

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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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