FDA 510(k)

HD腰椎椎间系统

K号: K170676 · 2017-07-13

决定日期2017-07-13

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

HD Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Hd Lifesciences, LLC. It received FDA 510(k) clearance on 2017-07-13 under 510(k) number K170676. 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 HD Lumbar Interbody System?

HD Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2017-07-13. The listed applicant is Hd Lifesciences, LLC. The 510(k) number is K170676.

When did HD Lumbar Interbody System receive FDA 510(k) clearance?

HD Lumbar Interbody System received FDA 510(k) clearance on 2017-07-13, under 510(k) number K170676.

Who is the listed applicant for HD Lumbar Interbody System?

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

What is the FDA product code for HD Lumbar Interbody System?

The FDA product code for HD Lumbar Interbody System is MAX.

列明Hd Lifesciences, 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。

K200541Hive™ 独立腰椎椎间系统 K180364HD LifeSciences 颈椎椎间融合系统

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

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。