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FDA 510(k)

加強柔軟膠原蛋白神經袖

K 號：K170656 · 2017-06-01

申請人Collagen Matrix, Inc.
決定日期2017-06-01
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

Reinforced Flexible Collagen Nerve Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2017-06-01 under 510(k) number K170656. 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 Reinforced Flexible Collagen Nerve Cuff?

Reinforced Flexible Collagen Nerve Cuff is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K170656.

When did Reinforced Flexible Collagen Nerve Cuff receive FDA 510(k) clearance?

Reinforced Flexible Collagen Nerve Cuff received FDA 510(k) clearance on 2017-06-01, under 510(k) number K170656.

Who is the listed applicant for Reinforced Flexible Collagen Nerve Cuff?

The FDA 510(k) record lists Collagen Matrix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reinforced Flexible Collagen Nerve Cuff?

The FDA product code for Reinforced Flexible Collagen Nerve Cuff is JXI.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Collagen Matrix, Inc. 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。

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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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