FDA 510(k)

MedCAD® AccuPlan® 系统

K号: K192282 · 2020-10-29

申请人Medcad

决定日期2020-10-29

产品代码DZJ

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决定实质等同

器械摘要

MedCAD® AccuPlan® System is the device name listed in this FDA 510(k) record. The listed applicant is Medcad. It received FDA 510(k) clearance on 2020-10-29 under 510(k) number K192282. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MedCAD® AccuPlan® System?

MedCAD® AccuPlan® System is a medical device that received FDA 510(k) clearance on 2020-10-29. The listed applicant is Medcad. The 510(k) number is K192282.

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

MedCAD® AccuPlan® System received FDA 510(k) clearance on 2020-10-29, under 510(k) number K192282.

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

The FDA product code for MedCAD® AccuPlan® System is DZJ.

列明Medcad为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252064MedCAD® AccuStride™ 系统 K251709MedCAD® AccuStride™ 系统 K241811MedCAD® AccuStride™ 系统 K230398MedCAD® AccuPlate® 3DTi 患者特异性接骨板系统 K223421MedCAD AccuPlan 骨科系统 K223024MedCAD AccuPlan 系统

查看所有 9 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。