FDA 510(k)

MedCAD® AccuStride™ 系統

K 號：K241811 · 2025-03-13

申請人Medcad

決定日期2025-03-13

產品代碼PBF

諮詢委員會或

決定相當於

器材摘要

MedCAD® AccuStride™ System is the device name listed in this FDA 510(k) record. The listed applicant is Medcad. It received FDA 510(k) clearance on 2025-03-13 under 510(k) number K241811. 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® AccuStride™ System?

MedCAD® AccuStride™ System is a medical device that received FDA 510(k) clearance on 2025-03-13. The listed applicant is Medcad. The 510(k) number is K241811.

When did MedCAD® AccuStride™ System receive FDA 510(k) clearance?

MedCAD® AccuStride™ System received FDA 510(k) clearance on 2025-03-13, under 510(k) number K241811.

Who is the listed applicant for MedCAD® AccuStride™ 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® AccuStride™ System?

The FDA product code for MedCAD® AccuStride™ 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 K230398MedCAD® AccuPlate® 3DTi 為患者量身定製板金系統 K223421MedCAD精準計劃骨科系統 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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