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FDA 510(k)

Phantom福岛神经系统固定系统，Phantom稳定性神经系统固定系统

K号: K161318 · 2017-03-20

申请人Tedan Surgical Innovations, LLC
决定日期2017-03-20
产品代码GZT
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决定实质等同

器械摘要

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems is the device name listed in this FDA 510(k) record. The listed applicant is Tedan Surgical Innovations, LLC. It received FDA 510(k) clearance on 2017-03-20 under 510(k) number K161318. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems?

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems is a medical device that received FDA 510(k) clearance on 2017-03-20. The listed applicant is Tedan Surgical Innovations, LLC. The 510(k) number is K161318.

When did Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems receive FDA 510(k) clearance?

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems received FDA 510(k) clearance on 2017-03-20, under 510(k) number K161318.

Who is the listed applicant for Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems?

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

What is the FDA product code for Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems?

The FDA product code for Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems is GZT.

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：GZT）

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。

K252995杜拉盾设备套件SurGenTec, LLCK210615汤普森脑拉钩桌式（TM），汤普森脑拉钩颅骨夹式（SCM）Thompson Surgical Instruments, Inc.K202694Vycor Medical 视频脑部接入系统（“VBAS”）及配备对齐夹的 VBAS（统称为“VBAS 系列产品”）Vycor Medical, Inc.K202072MindsEye 可扩展端口Minnetronix Neuro, Inc.K180610Geister神经和脊柱手术拉钩Geister Medizin Technik GmbHK172433NICO BrainPathNico Corporation

官方来源

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