FDA 510(k)

icotec 頸前板系統

K 號：K233215 · 2024-05-17

決定日期2024-05-17

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

icotec Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Icotec AG. It received FDA 510(k) clearance on 2024-05-17 under 510(k) number K233215. 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 icotec Anterior Cervical Plate System?

icotec Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2024-05-17. The listed applicant is Icotec AG. The 510(k) number is K233215.

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

icotec Anterior Cervical Plate System received FDA 510(k) clearance on 2024-05-17, under 510(k) number K233215.

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

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

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

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

其他以 Icotec AG 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。

K252327CMORE® CT系統；CMORE® CT系統導航儀器 K242900VADER®脊椎系統及VADER®one脊椎系統 K232792icotec 體內支架系統（icotec 頸椎支架，icotec PLIF 腰椎支架，icotec ETurn™ TLIF 腰椎支架）K232790KONG®-TL VBR 系統及 KONG® C VBR 系統 K232628VADER®脊椎系統 K230861VADER®脊椎系統導航儀器

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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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