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FDA 510(k)

神經防護盾

K 號：K190246 · 2019-05-31

申請人Monarch Bioimplants GmbH
決定日期2019-05-31
產品代碼JXI
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

NeuroShield is the device name listed in this FDA 510(k) record. The listed applicant is Monarch Bioimplants GmbH. It received FDA 510(k) clearance on 2019-05-31 under 510(k) number K190246. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NeuroShield?

NeuroShield is a medical device that received FDA 510(k) clearance on 2019-05-31. The listed applicant is Monarch Bioimplants GmbH. The 510(k) number is K190246.

When did NeuroShield receive FDA 510(k) clearance?

NeuroShield received FDA 510(k) clearance on 2019-05-31, under 510(k) number K190246.

Who is the listed applicant for NeuroShield?

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

What is the FDA product code for NeuroShield?

The FDA product code for NeuroShield is JXI.

相關臨床試驗

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相關器械（代碼：JXI）

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。

K260245SILKBridgeKLISBio S.r.l.K253363神經橋Auxilium Biotechnologies, Inc.K251505VersaCoat神經保護器（VTP-44G2）；VersaCoat神經保護器（VTP-12G1）Alafair BiosciencesK251175VersaWrap神經保護器（VTP-2201）；VersaWrap神經保護器（VTP-1201）Alafair BiosciencesK243889填補 (ON-152, 15 x 20 mm)；填補 (ON-203, 20 x 30 mm)；填補 (ON-304, 30 x 40 mm)；填補 (ON-405, 40 x 50 mm)Orthocell, Ltd.K242113神經包覆（07-DW-001-TAB）Biocircuit Technologies, Inc.

官方來源

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