FDA 510(k)

PathLoc 腰椎間融合金層系統

K 號：K251741 · 2025-07-08

決定日期2025-07-08

產品代碼MAX

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決定相當於

器材摘要

PathLoc Lumbar Interbody Fusion Cage 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 2025-07-08 under 510(k) number K251741. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PathLoc Lumbar Interbody Fusion Cage System?

PathLoc Lumbar Interbody Fusion Cage System is a medical device that received FDA 510(k) clearance on 2025-07-08. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K251741.

When did PathLoc Lumbar Interbody Fusion Cage System receive FDA 510(k) clearance?

PathLoc Lumbar Interbody Fusion Cage System received FDA 510(k) clearance on 2025-07-08, under 510(k) number K251741.

Who is the listed applicant for PathLoc Lumbar Interbody Fusion Cage 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 Lumbar Interbody Fusion Cage System?

The FDA product code for PathLoc Lumbar Interbody Fusion Cage System is MAX.

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：MAX）

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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