FDA 510(k)

Skyway前方颈椎板系統

K 號：K243015 · 2024-11-05

決定日期2024-11-05

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Skyway Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-11-05 under 510(k) number K243015. 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 Skyway Anterior Cervical Plate System?

Skyway Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2024-11-05. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K243015.

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

Skyway Anterior Cervical Plate System received FDA 510(k) clearance on 2024-11-05, under 510(k) number K243015.

Who is the listed applicant for Skyway Anterior Cervical Plate System?

FDA 510(k) 記錄將京瓷醫療技術股份有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Skyway Anterior Cervical Plate System?

The FDA product code for Skyway Anterior Cervical Plate System is KWQ.

其他以 Kyocera Medical Technologies, 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

官方來源

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