FDA 510(k)

單膝表面修復系統

K 號：K221292 · 2023-03-10

決定日期2023-03-10

產品代碼HSX

諮詢委員會或

決定相當於

器材摘要

Uni Knee Resurfacing System is the device name listed in this FDA 510(k) record. The listed applicant is Overture Resurfacing, Inc.. It received FDA 510(k) clearance on 2023-03-10 under 510(k) number K221292. 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 Uni Knee Resurfacing System?

Uni Knee Resurfacing System is a medical device that received FDA 510(k) clearance on 2023-03-10. The listed applicant is Overture Resurfacing, Inc.. The 510(k) number is K221292.

When did Uni Knee Resurfacing System receive FDA 510(k) clearance?

Uni Knee Resurfacing System received FDA 510(k) clearance on 2023-03-10, under 510(k) number K221292.

Who is the listed applicant for Uni Knee Resurfacing System?

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

What is the FDA product code for Uni Knee Resurfacing System?

The FDA product code for Uni Knee Resurfacing System is HSX.

其他以 Overture Resurfacing, 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。

K231253Overture骨科髌股系統

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。

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官方來源

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