FDA 510(k)

VersaCoat 軟骨保護器 (VTP-44G2)；VersaCoat 軟骨保護器 (VTP-12G1)

K 號：K251655 · 2025-07-18

決定日期2025-07-18

產品代碼OWW

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) is the device name listed in this FDA 510(k) record. The listed applicant is Alafair Biosciences. It received FDA 510(k) clearance on 2025-07-18 under 510(k) number K251655. The device is classified under product code OWW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)?

VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) is a medical device that received FDA 510(k) clearance on 2025-07-18. The listed applicant is Alafair Biosciences. The 510(k) number is K251655.

When did VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) receive FDA 510(k) clearance?

VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) received FDA 510(k) clearance on 2025-07-18, under 510(k) number K251655.

Who is the listed applicant for VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)?

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 VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)?

The FDA product code for VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) is OWW.

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）K251175VersaWrap神經保護器（VTP-2201）；VersaWrap神經保護器（VTP-1201）

相關器械（代碼：OWW）

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。

K250021羅蒂烏姆Nanofiber Solutions, LLC K242187BioBrace®Conmed Corporation K241906BioBrace® 加強植入體Conmed Corporation K240817VersaWrapAlafair Biosciences, Inc.K222220SpinMedix 可吸收性纖維膠膜Celestray Biotech Company, LLC.,K230316FlexBand；FlexPatch；FlexBand PlusInternational Life Sciences

官方來源

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