FDA 510(k)

Neo Cage System 商標

K 號：K181048 · 2019-01-29

決定日期2019-01-29

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Neo Cage System TM is the device name listed in this FDA 510(k) record. The listed applicant is Neo Medical SA. It received FDA 510(k) clearance on 2019-01-29 under 510(k) number K181048. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Neo Cage System TM?

Neo Cage System TM is a medical device that received FDA 510(k) clearance on 2019-01-29. The listed applicant is Neo Medical SA. The 510(k) number is K181048.

When did Neo Cage System TM receive FDA 510(k) clearance?

Neo Cage System TM received FDA 510(k) clearance on 2019-01-29, under 510(k) number K181048.

Who is the listed applicant for Neo Cage System TM?

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

What is the FDA product code for Neo Cage System TM?

The FDA product code for Neo Cage System TM is MAX.

其他以 Neo Medical 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。

K243693NEO椎板螺釘系統™K222256BonOs® 注射骨水泥；NEO 椎板螺釘系統™K212489BonOs 注射骨水泥；NEO 椎板螺釘系統 K191796Neo籠架系統 K171582NEO椎板螺釘系統™

相關器械（代碼：MAX）

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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