FDA 510(k)

ONX大型外固定系統

K 號：K213905 · 2022-08-25

決定日期2022-08-25

產品代碼KTT

諮詢委員會或

決定相當於

器材摘要

ONX Large External Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Orthonovis, Inc.. It received FDA 510(k) clearance on 2022-08-25 under 510(k) number K213905. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ONX Large External Fixation System?

ONX Large External Fixation System is a medical device that received FDA 510(k) clearance on 2022-08-25. The listed applicant is Orthonovis, Inc.. The 510(k) number is K213905.

When did ONX Large External Fixation System receive FDA 510(k) clearance?

ONX Large External Fixation System received FDA 510(k) clearance on 2022-08-25, under 510(k) number K213905.

Who is the listed applicant for ONX Large External Fixation System?

The FDA 510(k) record lists Orthonovis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONX Large External Fixation System?

The FDA product code for ONX Large External Fixation System is KTT.

其他以 Orthonovis, Inc. 為申請人之記錄

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相關器械（代碼：KTT）

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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