FDA 510(k)

Genesys Spine Apache® 前腰椎椎间融合系统

K号: K161438 · 2016-11-08

决定日期2016-11-08

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

Genesys Spine Apache® Anterior Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Genesys Spine. It received FDA 510(k) clearance on 2016-11-08 under 510(k) number K161438. 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 Genesys Spine Apache® Anterior Lumbar Interbody Fusion System?

Genesys Spine Apache® Anterior Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2016-11-08. The listed applicant is Genesys Spine. The 510(k) number is K161438.

When did Genesys Spine Apache® Anterior Lumbar Interbody Fusion System receive FDA 510(k) clearance?

Genesys Spine Apache® Anterior Lumbar Interbody Fusion System received FDA 510(k) clearance on 2016-11-08, under 510(k) number K161438.

Who is the listed applicant for Genesys Spine Apache® Anterior Lumbar Interbody Fusion System?

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

What is the FDA product code for Genesys Spine Apache® Anterior Lumbar Interbody Fusion System?

The FDA product code for Genesys Spine Apache® Anterior Lumbar Interbody Fusion System is MAX.

列明Genesys Spine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。

K252322SIros-X 系统 K242483Genesys Spine AIS-C II 颈椎椎间融合系统 K233595Genesys Spine Sacroiliac Joint Fusion System with Navigation K233594Genesys Spine 3DP AIS-C II 颈椎椎间融合系统 K220096Genesys Spine 3DP 腰椎椎间融合系统 K191489Genesys Spine 3DP 颈椎椎间融合系统

查看所有 21 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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