FDA 510(k)

VersaWrap 軟組織保護器

K 號：K160364 · 2016-06-10

決定日期2016-06-10

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

VersaWrap Tendon Protector is the device name listed in this FDA 510(k) record. The listed applicant is Alafair Biosciences, Inc.. It received FDA 510(k) clearance on 2016-06-10 under 510(k) number K160364. 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 VersaWrap Tendon Protector?

VersaWrap Tendon Protector is a medical device that received FDA 510(k) clearance on 2016-06-10. The listed applicant is Alafair Biosciences, Inc.. The 510(k) number is K160364.

When did VersaWrap Tendon Protector receive FDA 510(k) clearance?

VersaWrap Tendon Protector received FDA 510(k) clearance on 2016-06-10, under 510(k) number K160364.

Who is the listed applicant for VersaWrap Tendon Protector?

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

What is the FDA product code for VersaWrap Tendon Protector?

The FDA product code for VersaWrap Tendon Protector is OWW.

其他以 Alafair Biosciences, Inc. 為申請人之記錄

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K240817VersaWrap K232029VersaWrap 神經保護器 K213163VersaWrap K203600VersaWrap K201631VersaWrap 神經保護器 K200311VersaWrap 軟組織保護器

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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。

K251655VersaCoat 軟骨保護器 (VTP-44G2)；VersaCoat 軟骨保護器 (VTP-12G1)Alafair Biosciences 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.,

官方來源

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