FDA 510(k)

Fix2Lock（生物複合材中間、側邊，Biocombi 自擊釘）

K 號：K231326 · 2023-05-31

決定日期2023-05-31

產品代碼MAI

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器材摘要

Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) is the device name listed in this FDA 510(k) record. The listed applicant is Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2023-05-31 under 510(k) number K231326. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)?

Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) is a medical device that received FDA 510(k) clearance on 2023-05-31. The listed applicant is Osteonic Co., Ltd.. The 510(k) number is K231326.

When did Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) receive FDA 510(k) clearance?

Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) received FDA 510(k) clearance on 2023-05-31, under 510(k) number K231326.

Who is the listed applicant for Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)?

The FDA 510(k) record lists Osteonic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)?

The FDA product code for Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) is MAI.

其他以 Osteonic Co., Ltd. 為申請人之記錄

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相關器械（代碼：MAI）

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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