FDA 510(k)

導航手術套件

K 號：K231087 · 2023-08-16

申請人Implant Direct Sybron Manufacturing, LLC

決定日期2023-08-16

產品代碼DZI

諮詢委員會DE

決定相當於

器材摘要

Guided Surgery Kit is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2023-08-16 under 510(k) number K231087. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Guided Surgery Kit?

Guided Surgery Kit is a medical device that received FDA 510(k) clearance on 2023-08-16. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K231087.

When did Guided Surgery Kit receive FDA 510(k) clearance?

Guided Surgery Kit received FDA 510(k) clearance on 2023-08-16, under 510(k) number K231087.

Who is the listed applicant for Guided Surgery Kit?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Guided Surgery Kit?

The FDA product code for Guided Surgery Kit is DZI.

其他以 Implant Direct Sybron Manufacturing, LLC 為申請人之記錄

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相關器械（代碼：DZI）

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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