FDA 510(k)

內部關節穩定器 - 肘部

K 號：K223318 · 2023-05-10

決定日期2023-05-10

產品代碼OZI

諮詢委員會或

決定相當於

器材摘要

Internal Joint Stabilizer - Elbow is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2023-05-10 under 510(k) number K223318. The device is classified under product code OZI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Internal Joint Stabilizer - Elbow?

Internal Joint Stabilizer - Elbow is a medical device that received FDA 510(k) clearance on 2023-05-10. The listed applicant is Skeletal Dynamics, Inc.. The 510(k) number is K223318.

When did Internal Joint Stabilizer - Elbow receive FDA 510(k) clearance?

Internal Joint Stabilizer - Elbow received FDA 510(k) clearance on 2023-05-10, under 510(k) number K223318.

Who is the listed applicant for Internal Joint Stabilizer - Elbow?

FDA 510(k) 記錄將 Skeletal Dynamics, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Internal Joint Stabilizer - Elbow?

The FDA product code for Internal Joint Stabilizer - Elbow is OZI.

其他以 Skeletal Dynamics, Inc. 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：OZI）

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。

K231447雙內部關節穩定器- 肘部Skeletal Dynamics, Inc.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。