FDA 510(k)

MedCAD® AccuPlate® 3DTi 為患者量身定製板金系統

K 號：K230398 · 2023-09-26

申請人Medcad

決定日期2023-09-26

產品代碼JEY

諮詢委員會DE

決定相當於

器材摘要

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Medcad. It received FDA 510(k) clearance on 2023-09-26 under 510(k) number K230398. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MedCAD® AccuPlate® 3DTi Patient-Specific Plating System?

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is a medical device that received FDA 510(k) clearance on 2023-09-26. The listed applicant is Medcad. The 510(k) number is K230398.

When did MedCAD® AccuPlate® 3DTi Patient-Specific Plating System receive FDA 510(k) clearance?

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System received FDA 510(k) clearance on 2023-09-26, under 510(k) number K230398.

Who is the listed applicant for MedCAD® AccuPlate® 3DTi Patient-Specific Plating System?

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

What is the FDA product code for MedCAD® AccuPlate® 3DTi Patient-Specific Plating System?

The FDA product code for MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is JEY.

其他以 Medcad 為申請人之記錄

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相關器械（代碼：JEY）

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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