FDA 510(k)

PYXIS 3D 鈦金屬籠架系統

K 號：K223868 · 2023-04-26

決定日期2023-04-26

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

PYXIS 3D Titanium Cage System is the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-04-26 under 510(k) number K223868. 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 PYXIS 3D Titanium Cage System?

PYXIS 3D Titanium Cage System is a medical device that received FDA 510(k) clearance on 2023-04-26. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K223868.

When did PYXIS 3D Titanium Cage System receive FDA 510(k) clearance?

PYXIS 3D Titanium Cage System received FDA 510(k) clearance on 2023-04-26, under 510(k) number K223868.

Who is the listed applicant for PYXIS 3D Titanium Cage System?

FDA 510(k)記錄將GS Medical Co., Ltd.列為申請人。這本身並不足以確立設備製造商。

What is the FDA product code for PYXIS 3D Titanium Cage System?

The FDA product code for PYXIS 3D Titanium Cage System is MAX.

其他以 GS Medical 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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