FDA 510(k)

ALPHALOK 銅板系統

K 號：K221558 · 2022-11-15

決定日期2022-11-15

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

ALPHALOK Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Vilex, LLC. It received FDA 510(k) clearance on 2022-11-15 under 510(k) number K221558. 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 ALPHALOK Plating System?

ALPHALOK Plating System is a medical device that received FDA 510(k) clearance on 2022-11-15. The listed applicant is Vilex, LLC. The 510(k) number is K221558.

When did ALPHALOK Plating System receive FDA 510(k) clearance?

ALPHALOK Plating System received FDA 510(k) clearance on 2022-11-15, under 510(k) number K221558.

Who is the listed applicant for ALPHALOK Plating System?

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

What is the FDA product code for ALPHALOK Plating System?

The FDA product code for ALPHALOK Plating System is HRS.

其他以 Vilex, LLC 為申請人之記錄

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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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