免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Tailored-C Cervical Interbody Fusion System

K号: K200458 · 2020-12-28

申请人Bespoke Technologies
决定日期2020-12-28
产品代码ODP
咨询委员会OR 请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整： --- 产品名称：[产品名称] 公司名称：[公司名称] 根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。 产品注册号：[注册号] PMA编号：[PMA编号] 临床试验编号（NCT）：[NCT编号] PubMed ID（PMID）：[PMID编号] 更多信息请访问以下链接： [URL] --- 请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。
决定实质等同

器械摘要

Tailored-C Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Bespoke Technologies. It received FDA 510(k) clearance on 2020-12-28 under 510(k) number K200458. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tailored-C Cervical Interbody Fusion System?

Tailored-C Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2020-12-28. The listed applicant is Bespoke Technologies. The 510(k) number is K200458.

When did Tailored-C Cervical Interbody Fusion System receive FDA 510(k) clearance?

Tailored-C Cervical Interbody Fusion System received FDA 510(k) clearance on 2020-12-28, under 510(k) number K200458.

Who is the listed applicant for Tailored-C Cervical Interbody Fusion System?

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

What is the FDA product code for Tailored-C Cervical Interbody Fusion System?

The FDA product code for Tailored-C Cervical Interbody Fusion System is ODP.

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：ODP）

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。

K262595VariLift-C 颈椎椎间融合系统Wenzel Spine, Inc.K262489BluEX宫颈可扩张笼系统L&K BIOMED Co., Ltd.K2530413D颈椎笼Fims Co., Ltd.K262061Tritanium® C 前颈椎笼；Tritanium® PL笼；Tritanium® TL弯曲腰椎笼；Aero® -C 颈椎笼系统；AVS® Anchor-C 颈椎笼系统；AVS® TL PEEK间隔器；AVS® PL PEEK间隔器；AVS® 导航PEEK间隔器；AVS® AS PEEK间隔器；Monterey™ AL椎间系统；Aleutian IBF系统；Cascadia椎间系统；Chesapeake稳定系统；Sahara稳定系统；SANTORINI™ 脱位椎体笼系统；MOJAVE椎间系统；VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. 医疗椎间融合系统C.A. Medical, LLCK260840BluEX宫颈可扩张笼系统L&K BIOMED Co., Ltd.

官方来源

在 FDA 数据库中查看 →

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。

↑