FDA 510(k)

Renovis A200 PS 適合膝系統，為 Renovis A200 膝關節系統的一部分

K 號：K190122 · 2019-06-20

決定日期2019-06-20

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

Renovis A200 PS Knee System as part of the Renovis A200 Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Renovis Surgical Technologies. It received FDA 510(k) clearance on 2019-06-20 under 510(k) number K190122. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Renovis A200 PS Knee System as part of the Renovis A200 Knee System?

Renovis A200 PS Knee System as part of the Renovis A200 Knee System is a medical device that received FDA 510(k) clearance on 2019-06-20. The listed applicant is Renovis Surgical Technologies. The 510(k) number is K190122.

When did Renovis A200 PS Knee System as part of the Renovis A200 Knee System receive FDA 510(k) clearance?

Renovis A200 PS Knee System as part of the Renovis A200 Knee System received FDA 510(k) clearance on 2019-06-20, under 510(k) number K190122.

Who is the listed applicant for Renovis A200 PS Knee System as part of the Renovis A200 Knee System?

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

What is the FDA product code for Renovis A200 PS Knee System as part of the Renovis A200 Knee System?

The FDA product code for Renovis A200 PS Knee System as part of the Renovis A200 Knee System is JWH.

其他以 Renovis Surgical Technologies 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。

K182007Renovis Tesera C/Tesera SC 前頸椎融合（ACF）系統 K181655Renovis S180 邊側腰椎間融合系統 K171543Renovis外科人工髋關節置換系統 K170888Renovis S141 腰椎間融合系統 K153250Renovis Tesera SC 独立式前頸融合（ACF）系統

相關器械（代碼：JWH）

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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