FDA 510(k)

蒙白山及蒙白山MIS脊椎系統

K 號：K161387 · 2016-08-04

決定日期2016-08-04

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Mont Blanc and Mont Blanc MIS Spinal Systems is the device name listed in this FDA 510(k) record. The listed applicant is Spineway SA. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K161387. 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 Mont Blanc and Mont Blanc MIS Spinal Systems?

Mont Blanc and Mont Blanc MIS Spinal Systems is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Spineway SA. The 510(k) number is K161387.

When did Mont Blanc and Mont Blanc MIS Spinal Systems receive FDA 510(k) clearance?

Mont Blanc and Mont Blanc MIS Spinal Systems received FDA 510(k) clearance on 2016-08-04, under 510(k) number K161387.

Who is the listed applicant for Mont Blanc and Mont Blanc MIS Spinal Systems?

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

What is the FDA product code for Mont Blanc and Mont Blanc MIS Spinal Systems?

The FDA product code for Mont Blanc and Mont Blanc MIS Spinal Systems is NKB.

其他以 Spineway SA 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。

K191726蒙白與蒙白 MIS 腰椎系統

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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