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FDA 510(k)

颅面颌面固定系统（CMF）- CMF Visionare

K号: K180204 · 2018-12-28

申请人Visionare, LLC
决定日期2018-12-28
产品代码JEY
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决定实质等同

器械摘要

CranioMaxillofacial Fixation (CMF) System - CMF Visionare is the device name listed in this FDA 510(k) record. The listed applicant is Visionare, LLC. It received FDA 510(k) clearance on 2018-12-28 under 510(k) number K180204. 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 CranioMaxillofacial Fixation (CMF) System - CMF Visionare?

CranioMaxillofacial Fixation (CMF) System - CMF Visionare is a medical device that received FDA 510(k) clearance on 2018-12-28. The listed applicant is Visionare, LLC. The 510(k) number is K180204.

When did CranioMaxillofacial Fixation (CMF) System - CMF Visionare receive FDA 510(k) clearance?

CranioMaxillofacial Fixation (CMF) System - CMF Visionare received FDA 510(k) clearance on 2018-12-28, under 510(k) number K180204.

Who is the listed applicant for CranioMaxillofacial Fixation (CMF) System - CMF Visionare?

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

What is the FDA product code for CranioMaxillofacial Fixation (CMF) System - CMF Visionare?

The FDA product code for CranioMaxillofacial Fixation (CMF) System - CMF Visionare is JEY.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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 CorporationK253373Southern 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 OYK241314KLS Martin 口腔-Max 嵌入物 MR 条件性（捆绑）KLS-Martin L.P.

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