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FDA 510(k)

CORNERSTONE PSR 颈椎融合系统，PERIMETER C 脊柱系统，PEEK PREVAIL 颈椎椎间融合器

K号: K153373 · 2016-01-19

申请人Medtronic Sofamor Danek
决定日期2016-01-19
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

CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2016-01-19 under 510(k) number K153373. 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 CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device?

CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device is a medical device that received FDA 510(k) clearance on 2016-01-19. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K153373.

When did CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device receive FDA 510(k) clearance?

CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device received FDA 510(k) clearance on 2016-01-19, under 510(k) number K153373.

Who is the listed applicant for CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device?

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

What is the FDA product code for CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device?

The FDA product code for CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device 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

列明Medtronic Sofamor Danek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。

K212428Centerpiece板固定系统K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyK173125T2 STRATOSPHERE™ Expandable Corpectomy SystemK172199ELEVATE 脊柱系统，CAPSTONE PTC 脊柱系统，CRESCENT 脊柱系统，CRESCENT 脊柱系统钛合金K171031CRESCENT™ 脊柱系统K171468FUSE 脊柱系统

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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

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