FDA 510(k)

EVOS 閃光板

K 號：K240487 · 2024-09-03

決定日期2024-09-03

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

EVOS Patella Plates is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew. It received FDA 510(k) clearance on 2024-09-03 under 510(k) number K240487. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EVOS Patella Plates?

EVOS Patella Plates is a medical device that received FDA 510(k) clearance on 2024-09-03. The listed applicant is Smith & Nephew. The 510(k) number is K240487.

When did EVOS Patella Plates receive FDA 510(k) clearance?

EVOS Patella Plates received FDA 510(k) clearance on 2024-09-03, under 510(k) number K240487.

Who is the listed applicant for EVOS Patella Plates?

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

What is the FDA product code for EVOS Patella Plates?

The FDA product code for EVOS Patella Plates is HRS.

其他以 Smith & Nephew 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：HRS）

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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