FDA 510(k)

PTG-05

K 號：K240347 · 2024-07-21

決定日期2024-07-21

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

PTG-05 is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Medizinsysteme GmbH. It received FDA 510(k) clearance on 2024-07-21 under 510(k) number K240347. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PTG-05?

PTG-05 is a medical device that received FDA 510(k) clearance on 2024-07-21. The listed applicant is Zimmer Medizinsysteme GmbH. The 510(k) number is K240347.

When did PTG-05 receive FDA 510(k) clearance?

PTG-05 received FDA 510(k) clearance on 2024-07-21, under 510(k) number K240347.

Who is the listed applicant for PTG-05?

The FDA 510(k) record lists Zimmer Medizinsysteme GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PTG-05?

The FDA product code for PTG-05 is NGX.

其他以 Zimmer Medizinsysteme GmbH 為申請人之記錄

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相關器械（代碼：NGX）

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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