FDA 510(k)

icotec 頸椎籠

K 號：K192897 · 2020-03-20

決定日期2020-03-20

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

icotec Cervical Cage is the device name listed in this FDA 510(k) record. The listed applicant is Icotec AG. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K192897. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the icotec Cervical Cage?

icotec Cervical Cage is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Icotec AG. The 510(k) number is K192897.

When did icotec Cervical Cage receive FDA 510(k) clearance?

icotec Cervical Cage received FDA 510(k) clearance on 2020-03-20, under 510(k) number K192897.

Who is the listed applicant for icotec Cervical Cage?

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 Cervical Cage?

The FDA product code for icotec Cervical Cage is ODP.

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 K233215icotec 頸前板系統 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

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相關器械（代碼：ODP）

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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官方來源

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