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FDA 510(k)

Integra® CAPTURE™螺钉系统和Integra® Ti6®内部固定系统

K号: K162153 · 2017-07-14

申请人Ascension Orthopedics
决定日期2017-07-14
产品代码HWC
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

Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Ascension Orthopedics. It received FDA 510(k) clearance on 2017-07-14 under 510(k) number K162153. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System?

Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is Ascension Orthopedics. The 510(k) number is K162153.

When did Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System receive FDA 510(k) clearance?

Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System received FDA 510(k) clearance on 2017-07-14, under 510(k) number K162153.

Who is the listed applicant for Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System?

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

What is the FDA product code for Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System?

The FDA product code for Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System is HWC. This falls under the Cardiovascular category.

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Ascension Orthopedics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。

K182878Integra Salto 总踝关节系统K160830Integra 外部固定系统

相关器械（代码：HWC）

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。

K262975Arthrex Beaming系统Arthrex, Inc.K260995DynaNail螺旋®固定系统MedShape, Inc.K254280F.A.S.T. 螺丝Steps OrthoK261057ActivaScrew™ 穿刺式 COMBioretec, Ltd.K260106OsteoCoil™ GT 活动压缩系统Flower Orthopedics Corporation DBA Conventus Flower OrthopedK262344大型压缩螺钉TriMed, Inc.

官方来源

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