FDA 510(k)

ZION 頸椎前方固定系統

K 號：K160702 · 2016-08-23

決定日期2016-08-23

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

ZION Anterior Cervical Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical. It received FDA 510(k) clearance on 2016-08-23 under 510(k) number K160702. 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 ZION Anterior Cervical Fixation System?

ZION Anterior Cervical Fixation System is a medical device that received FDA 510(k) clearance on 2016-08-23. The listed applicant is Astura Medical. The 510(k) number is K160702.

When did ZION Anterior Cervical Fixation System receive FDA 510(k) clearance?

ZION Anterior Cervical Fixation System received FDA 510(k) clearance on 2016-08-23, under 510(k) number K160702.

Who is the listed applicant for ZION Anterior Cervical Fixation System?

The FDA 510(k) record lists Astura Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZION Anterior Cervical Fixation System?

The FDA product code for ZION Anterior Cervical Fixation System is KWQ.

其他以 Astura Medical 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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