FDA 510(k)

雙內部關節穩定器- 肘部

K 號：K231447 · 2023-12-15

決定日期2023-12-15

產品代碼OZI

諮詢委員會或

決定相當於

器材摘要

Double 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 2023-12-15 under 510(k) number K231447. 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 Double Internal Joint Stabilizer- Elbow?

Double Internal Joint Stabilizer- Elbow is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Skeletal Dynamics, Inc.. The 510(k) number is K231447.

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

Double Internal Joint Stabilizer- Elbow received FDA 510(k) clearance on 2023-12-15, under 510(k) number K231447.

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

The FDA product code for Double 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。

K223318內部關節穩定器 - 肘部Skeletal Dynamics, Inc.

官方來源

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