FDA 510(k)

PathLoc 骨盆關節融合系統

K 號：K240201 · 2024-02-23

決定日期2024-02-23

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

PathLoc SI Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2024-02-23 under 510(k) number K240201. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PathLoc SI Joint Fusion System?

PathLoc SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2024-02-23. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K240201.

When did PathLoc SI Joint Fusion System receive FDA 510(k) clearance?

PathLoc SI Joint Fusion System received FDA 510(k) clearance on 2024-02-23, under 510(k) number K240201.

Who is the listed applicant for PathLoc SI Joint Fusion System?

FDA 510(k) 記錄將 L&K BIOMED Co., Ltd. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for PathLoc SI Joint Fusion System?

The FDA product code for PathLoc SI Joint Fusion System is OUR.

其他以 L&K BIOMED Co., Ltd. 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。

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相關器械（代碼：OUR）

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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官方來源

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