FDA 510(k)

飛馬-X 可擴展 PLIF 系統

K 號：K221687 · 2022-07-27

決定日期2022-07-27

產品代碼MAX

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決定相當於

器材摘要

Pegasus-X Expandable PLIF 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 2022-07-27 under 510(k) number K221687. 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 Pegasus-X Expandable PLIF System?

Pegasus-X Expandable PLIF System is a medical device that received FDA 510(k) clearance on 2022-07-27. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K221687.

When did Pegasus-X Expandable PLIF System receive FDA 510(k) clearance?

Pegasus-X Expandable PLIF System received FDA 510(k) clearance on 2022-07-27, under 510(k) number K221687.

Who is the listed applicant for Pegasus-X Expandable PLIF 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 Pegasus-X Expandable PLIF System?

The FDA product code for Pegasus-X Expandable PLIF System is MAX.

其他以 GS Medical Co., Ltd. 為申請人之記錄

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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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