FDA 510(k)

EMERGE™ 頸前板系統

K 號：K212405 · 2021-09-30

決定日期2021-09-30

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

EMERGE™ Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Evolution Spine. It received FDA 510(k) clearance on 2021-09-30 under 510(k) number K212405. 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 EMERGE™ Anterior Cervical Plate System?

EMERGE™ Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2021-09-30. The listed applicant is Evolution Spine. The 510(k) number is K212405.

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

EMERGE™ Anterior Cervical Plate System received FDA 510(k) clearance on 2021-09-30, under 510(k) number K212405.

Who is the listed applicant for EMERGE™ Anterior Cervical Plate System?

FDA 510(k) 記錄將 Evolution Spine 列為申請人。這並不單獨確立設備製造商。

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

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

其他以 Evolution Spine 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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