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FDA 510(k)

Axoguard HA+ 神經保護器 (AGHA12)；Axoguard HA+ 神經保護器 (AGHA22)；Axoguard HA+ 神經保護器 (AGHA24)；Axoguard HA+ 神經保護器 (AGHA36)；Axoguard HA+ 神經保護器 (AGHA48)

K 號：K223640 · 2023-04-07

申請人Axogen Corporation
決定日期2023-04-07
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

Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) is the device name listed in this FDA 510(k) record. The listed applicant is Axogen Corporation. It received FDA 510(k) clearance on 2023-04-07 under 510(k) number K223640. 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 Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)?

Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) is a medical device that received FDA 510(k) clearance on 2023-04-07. The listed applicant is Axogen Corporation. The 510(k) number is K223640.

When did Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) receive FDA 510(k) clearance?

Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) received FDA 510(k) clearance on 2023-04-07, under 510(k) number K223640.

Who is the listed applicant for Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)?

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

What is the FDA product code for Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)?

The FDA product code for Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) 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 Axogen Corporation 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。

K231708Axoguard HA+ 神經保護器 (AGHA12)；Axoguard HA+ 神經保護器 (AGHA22)；Axoguard HA+ 神經保護器 (AGHA24)；Axoguard HA+ 神經保護器 (AGHA36)；Axoguard HA+ 神經保護器 (AGHA48)K163446AxoGen 神經帽

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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