FDA 510(k)

EVOL 腰椎椎间融合系统, EVOS 腰椎椎间融合系统

K号: K180891 · 2018-05-04

决定日期2018-05-04

产品代码MAX

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

EVOL Spinal Interbody System, EVOS Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Cutting Edge Spine, LLC. It received FDA 510(k) clearance on 2018-05-04 under 510(k) number K180891. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EVOL Spinal Interbody System, EVOS Lumbar Interbody System?

EVOL Spinal Interbody System, EVOS Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2018-05-04. The listed applicant is Cutting Edge Spine, LLC. The 510(k) number is K180891.

When did EVOL Spinal Interbody System, EVOS Lumbar Interbody System receive FDA 510(k) clearance?

EVOL Spinal Interbody System, EVOS Lumbar Interbody System received FDA 510(k) clearance on 2018-05-04, under 510(k) number K180891.

Who is the listed applicant for EVOL Spinal Interbody System, EVOS Lumbar Interbody System?

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

What is the FDA product code for EVOL Spinal Interbody System, EVOS Lumbar Interbody System?

The FDA product code for EVOL Spinal Interbody System, EVOS Lumbar Interbody System is MAX.

列明Cutting Edge Spine, LLC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。

K250605EVOL® ha – Hyper C 颈椎间融合系统 K230689T-FIX® 3DSI关节融合系统 K214123T-FIX® 3DSI关节融合系统 K200991EVOL 腰椎椎间融合系统 K200552EVOS 腰椎间融合系统 K192497EVOL ha - D 横向椎间融合系统

查看所有 9 个设备 →

相关器械（代码：MAX）

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。

K261049SCALA® TLSpineart SA K261430TruLift可扩展系统Life Spine, Inc.K253011Catalyft PL 可扩张椎间系统Medtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L 脊柱系统Medtronic Sofamor Danek USA, Inc.K253420Admiral ACP系统；Explorer TO系统；Laminoplasty系统；Manta Ray TDF间隔器；Meridian椎间系统；Meridian前板系统；Reef L椎间系统；Reef TO/TA系统；Regatta L侧系统；Regatta L侧板系统；Shoreline ACS椎间系统；Shoreline螺纹TruProfile板；Shoreline RT椎间系统；Vu网格；WaveForm A椎间系统；WaveForm C椎间系统；WaveForm L椎间系统；WaveForm TA椎间系统；WaveForm TO椎间系统SeaSpine Orthopedics Corporation K253151富乐椎间融合笼系统Beijing Fule Science & Technology Development Co., Ltd.

官方来源

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