FDA 510(k)

MVP脊椎板系統

K 號：K190170 · 2019-05-13

決定日期2019-05-13

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

MVP Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-05-13 under 510(k) number K190170. 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 MVP Cervical Plate System?

MVP Cervical Plate System is a medical device that received FDA 510(k) clearance on 2019-05-13. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K190170.

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

MVP Cervical Plate System received FDA 510(k) clearance on 2019-05-13, under 510(k) number K190170.

Who is the listed applicant for MVP Cervical Plate System?

FDA 510(k)記錄將GS Medical Co., Ltd.列為申請人。這本身並不足以確立設備製造商。

What is the FDA product code for MVP Cervical Plate System?

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

其他以 GS Medical Co., Ltd. 為申請人之記錄

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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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