FDA 510(k)

雅典娜宫颈板系统

K 號：K180022 · 2018-07-20

決定日期2018-07-20

產品代碼KWQ

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決定相當於

器材摘要

Athena 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 2018-07-20 under 510(k) number K180022. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Athena Cervical Plate System?

Athena Cervical Plate System is a medical device that received FDA 510(k) clearance on 2018-07-20. The listed applicant is Medyssey USA, Inc.. The 510(k) number is K180022.

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

Athena Cervical Plate System received FDA 510(k) clearance on 2018-07-20, under 510(k) number K180022.

Who is the listed applicant for Athena 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 Cervical Plate System?

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

其他以 Medyssey USA, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：KWQ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262149corra®脊椎板系統Carlsmed, Inc.K261309Palisades™ 壁壘板系統Bethesda Medical Devices, LLC K252776ARIES 前頸椎板系統ZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P 頸椎前方板系統L&K BIOMED Co., Ltd.K260570corra™脊椎板系統Carlsmed, Inc.K260697VyPlate™ 頸椎前方板系統Vy Spine, LLC

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