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FDA 510(k)

Athena II Cervical Plate System

K-Number: K183409 · 2019-02-11

ApplicantMedyssey USA, Inc.
Decision Date2019-02-11
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Athena II Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Medyssey USA, Inc.. It received FDA 510(k) clearance on 2019-02-11 under 510(k) number K183409. 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 Athena II Cervical Plate System?

Athena II Cervical Plate System is a medical device that received FDA 510(k) clearance on 2019-02-11. The listed applicant is Medyssey USA, Inc.. The 510(k) number is K183409.

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

Athena II Cervical Plate System received FDA 510(k) clearance on 2019-02-11, under 510(k) number K183409.

Who is the listed applicant for Athena II Cervical Plate System?

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

What is the FDA product code for Athena II Cervical Plate System?

The FDA product code for Athena II Cervical Plate System is KWQ.

Other records listing Medyssey USA, 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.

K232218Zenius™ Spinal SystemK230301Athena III Cervical Plate SystemK223654Medussa-PL CageK200283Medussa-PL CageK183407Triton CageK181978Zenius™, Iliad™ and Kora™ Spinal Fixation Systems

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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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