FDA 510(k)

ELEVATE 脊柱系统，CAPSTONE PTC 脊柱系统，CRESCENT 脊柱系统，CRESCENT 脊柱系统钛合金

K号: K172199 · 2017-09-19

决定日期2017-09-19

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

ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium 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 2017-09-19 under 510(k) number K172199. 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 ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium?

ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium is a medical device that received FDA 510(k) clearance on 2017-09-19. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K172199.

When did ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium receive FDA 510(k) clearance?

ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium received FDA 510(k) clearance on 2017-09-19, under 510(k) number K172199.

Who is the listed applicant for ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium?

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 ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium?

The FDA product code for ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium is MAX.

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 Technology K173125T2 STRATOSPHERE™ Expandable Corpectomy System K171031CRESCENT™ 脊柱系统 K171468FUSE 脊柱系统 K170679CD HORIZON®脊柱系统，Medtronic可重复使用工具，用于IPC® POWEREASE®系统，Medtronic导航可重复使用工具，用于STEALTHSTATION®和IPC® POWEREASE®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

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。