FDA 510(k)

MedCAD精準計劃骨科系統

K 號：K223421 · 2023-09-20

申請人Medcad

決定日期2023-09-20

產品代碼PBF

諮詢委員會或

決定相當於

器材摘要

MedCAD AccuPlan Orthopedics System is the device name listed in this FDA 510(k) record. The listed applicant is Medcad. It received FDA 510(k) clearance on 2023-09-20 under 510(k) number K223421. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MedCAD AccuPlan Orthopedics System?

MedCAD AccuPlan Orthopedics System is a medical device that received FDA 510(k) clearance on 2023-09-20. The listed applicant is Medcad. The 510(k) number is K223421.

When did MedCAD AccuPlan Orthopedics System receive FDA 510(k) clearance?

MedCAD AccuPlan Orthopedics System received FDA 510(k) clearance on 2023-09-20, under 510(k) number K223421.

Who is the listed applicant for MedCAD AccuPlan Orthopedics 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 AccuPlan Orthopedics System?

The FDA product code for MedCAD AccuPlan Orthopedics System is PBF.

其他以 Medcad 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。

K252064MedCAD® AccuStride™ 系統 K251709MedCAD® AccuStride™ 系統 K241811MedCAD® AccuStride™ 系統 K230398MedCAD® AccuPlate® 3DTi 為患者量身定製板金系統 K223024MedCAD精準計劃系統 K220357MedCAD AccuShape 鈦金屬病人專屬頭蓋植入體

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相關器械（代碼：PBF）

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。

K252064MedCAD® AccuStride™ 系統Medcad K250711VSP骨科系統3D Systems, Inc.K242603MyPAO SA 指導Medacta International S.A.K251709MedCAD® AccuStride™ 系統Medcad K250394精細TTO™Bodycad Laboratories, Inc.K250767Newclip 患者匹配儀器非無菌 PSINewclip Technics

官方來源

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