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FDA 510(k)

Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System

K-Number: K223719 · 2023-01-11

ApplicantAegis Spine, Inc.
Decision Date2023-01-11
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Aegis Spine, Inc.. It received FDA 510(k) clearance on 2023-01-11 under 510(k) number K223719. 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 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System?

Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2023-01-11. The listed applicant is Aegis Spine, Inc.. The 510(k) number is K223719.

When did Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System receive FDA 510(k) clearance?

Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System received FDA 510(k) clearance on 2023-01-11, under 510(k) number K223719.

Who is the listed applicant for Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System?

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

What is the FDA product code for Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System?

The FDA product code for Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System is KWQ.

Related Clinical Trials

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.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

Other records listing Aegis Spine, 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.

K223521ZESPIN SI Joint Fusion SystemK221719ABTross ALIF Expandable Cage SystemK221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate SystemK210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate SystemK203531XYPAN Expandable Lumbar Cage System

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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