FDA 510(k)

意願植板系統

K 號：K210658 · 2021-04-13

決定日期2021-04-13

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Volition Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Solutions UK , Ltd.. It received FDA 510(k) clearance on 2021-04-13 under 510(k) number K210658. 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 Volition Plating System?

Volition Plating System is a medical device that received FDA 510(k) clearance on 2021-04-13. The listed applicant is Ortho Solutions UK , Ltd.. The 510(k) number is K210658.

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

Volition Plating System received FDA 510(k) clearance on 2021-04-13, under 510(k) number K210658.

Who is the listed applicant for Volition Plating System?

The FDA 510(k) record lists Ortho Solutions UK , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Volition Plating System?

The FDA product code for Volition Plating System is HRS.

其他以 Ortho Solutions UK , Ltd. 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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官方來源

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