FDA 510(k)

icotec脊椎系統

K 號：K151977 · 2016-04-12

決定日期2016-04-12

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

icotec Pedicle 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 2016-04-12 under 510(k) number K151977. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the icotec Pedicle System?

icotec Pedicle System is a medical device that received FDA 510(k) clearance on 2016-04-12. The listed applicant is Icotec AG. The 510(k) number is K151977.

When did icotec Pedicle System receive FDA 510(k) clearance?

icotec Pedicle System received FDA 510(k) clearance on 2016-04-12, under 510(k) number K151977.

Who is the listed applicant for icotec Pedicle 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 Pedicle System?

The FDA product code for icotec Pedicle System is NKB.

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：NKB）

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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