FDA 510(k)

VADER® 一體式椎板系統 MIS 及 LightMore® 椎板系統 6.0

K 號：K190545 · 2019-06-20

決定日期2019-06-20

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 is the device name listed in this FDA 510(k) record. The listed applicant is Icotec AG. It received FDA 510(k) clearance on 2019-06-20 under 510(k) number K190545. 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 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0?

VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 is a medical device that received FDA 510(k) clearance on 2019-06-20. The listed applicant is Icotec AG. The 510(k) number is K190545.

When did VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 receive FDA 510(k) clearance?

VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 received FDA 510(k) clearance on 2019-06-20, under 510(k) number K190545.

Who is the listed applicant for VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0?

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 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0?

The FDA product code for VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 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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