FDA 510(k)

MedCAD® AccuPlate® 3DTi 患者特异性接骨板系统

K号: K230398 · 2023-09-26

申请人Medcad

决定日期2023-09-26

产品代码JEY

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决定实质等同

器械摘要

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.

常见问题

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.

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 K223421MedCAD AccuPlan 骨科系统 K223024MedCAD AccuPlan 系统 K220357MedCAD AccuShape 钛合金患者特异性颅骨植入物

查看所有 9 个设备 →

相关器械（代码：JEY）

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。

K260137KLS Martin IPS 口腔-Max 种植体 - MR 条件性；个体化患者解决方案 - Ti (IPS-Ti)；个体化患者解决方案 - PEEK (IPS-PEEK)；KLS Martin 个体化患者解决方案KLS-Martin L.P.K253206细致入微的个性化CMF解决方案Meticuly Co., Ltd.K252246Leforte MMF 系统Jeil Medical Corporation K253373Southern 颅面 (CMF) 系统Southern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby生物可吸收固定系统；Inion CPS 1.5/2.0/2.5生物可吸收固定系统Inion OY K241314KLS Martin 口腔-Max 嵌入物 MR 条件性（捆绑）KLS-Martin L.P.

官方来源

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