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FDA 510(k)

OvertureTi 適用膝蓋表面修復系統™

K 號:K242746 · 2024-10-07

決定日期2024-10-07
產品代碼HSX
諮詢委員會或
決定相當於

器材摘要

OvertureTi Knee Resurfacing SystemTM is the device name listed in this FDA 510(k) record. The listed applicant is Overture Orthopaedics. It received FDA 510(k) clearance on 2024-10-07 under 510(k) number K242746. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OvertureTi Knee Resurfacing SystemTM?

OvertureTi Knee Resurfacing SystemTM is a medical device that received FDA 510(k) clearance on 2024-10-07. The listed applicant is Overture Orthopaedics. The 510(k) number is K242746.

When did OvertureTi Knee Resurfacing SystemTM receive FDA 510(k) clearance?

OvertureTi Knee Resurfacing SystemTM received FDA 510(k) clearance on 2024-10-07, under 510(k) number K242746.

Who is the listed applicant for OvertureTi Knee Resurfacing SystemTM?

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

What is the FDA product code for OvertureTi Knee Resurfacing SystemTM?

The FDA product code for OvertureTi Knee Resurfacing SystemTM is HSX.

相關臨床試驗

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相關器械(代碼:HSX)

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。

官方來源

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