FDA 510(k)

Prime及DYNASTY® 增材製造殼

K 號：K202705 · 2021-08-20

決定日期2021-08-20

產品代碼OQG

諮詢委員會或

決定相當於

器材摘要

Prime and DYNASTY® Additive Manufacturing Shells is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2021-08-20 under 510(k) number K202705. The device is classified under product code OQG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Prime and DYNASTY® Additive Manufacturing Shells?

Prime and DYNASTY® Additive Manufacturing Shells is a medical device that received FDA 510(k) clearance on 2021-08-20. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K202705.

When did Prime and DYNASTY® Additive Manufacturing Shells receive FDA 510(k) clearance?

Prime and DYNASTY® Additive Manufacturing Shells received FDA 510(k) clearance on 2021-08-20, under 510(k) number K202705.

Who is the listed applicant for Prime and DYNASTY® Additive Manufacturing Shells?

FDA 510(k) 記錄將 Microport Orthopedics, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Prime and DYNASTY® Additive Manufacturing Shells?

The FDA product code for Prime and DYNASTY® Additive Manufacturing Shells is OQG.

其他以 Microport Orthopedics, 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。

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相關器械（代碼：OQG）

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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