FDA 510(k)

VersaWrap神經保護器（VTP-2201）；VersaWrap神經保護器（VTP-1201）

K 號：K251175 · 2025-07-17

決定日期2025-07-17

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

VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) is the device name listed in this FDA 510(k) record. The listed applicant is Alafair Biosciences. It received FDA 510(k) clearance on 2025-07-17 under 510(k) number K251175. 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 VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)?

VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) is a medical device that received FDA 510(k) clearance on 2025-07-17. The listed applicant is Alafair Biosciences. The 510(k) number is K251175.

When did VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) receive FDA 510(k) clearance?

VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) received FDA 510(k) clearance on 2025-07-17, under 510(k) number K251175.

Who is the listed applicant for VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)?

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

What is the FDA product code for VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)?

The FDA product code for VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) is JXI.

其他以 Alafair Biosciences 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。

K251505VersaCoat神經保護器（VTP-44G2）；VersaCoat神經保護器（VTP-12G1）K251655VersaCoat 軟骨保護器 (VTP-44G2)；VersaCoat 軟骨保護器 (VTP-12G1)

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 Biosciences K243889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.K233322森田神經袖Mochida Pharmaceutical Co., Ltd.

官方來源

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