FDA 510(k)

Trident® II Tritanium® 髋臼杯和6.5毫米低轮廓六角螺钉

K号: K161569 · 2016-10-14

申请人Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

决定日期2016-10-14

产品代码LPH

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

Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K161569. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws?

Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K161569.

When did Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws receive FDA 510(k) clearance?

Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161569.

Who is the listed applicant for Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws?

The FDA 510(k) record lists Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws?

The FDA product code for Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws is LPH.

列明Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics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。

K233261全球模块化替换系统 K210893Restoration解剖壳 K203099铁人三项PKR系统 K191358特里登II髋臼系统 K182468Trident X3 髋臼杯植入物，ADM 和 MDM X3 髋臼杯植入物，Accolade II 髋关节系统 K180612铁人三项PKR X3胫骨插入物，Mako X3单层胫骨插入物

查看所有 9 个设备 →

相关器械（代码：LPH）

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。

K261453G7® 髋臼系统Zimmer Biomet K253630Mpact 3D金属泡沫Medacta International S.A.K254043TRIVANCE™ 髋关节假体Globus Medical, Inc.K261624Omnifit® 20°系列I插入件；Omnifit® Crossfire® 10°系列II插入件；限制性髋臼插入件；Trident® Crossfire® 0°聚乙烯插入件；Trident® Crossfire® 10°聚乙烯插入件；System 12 Crossfire® 10°插入件；Trident® 0°限制性髋臼插入件；Trident® 限制性髋臼衬垫；Trident® 全聚乙烯限制性髋臼插入件；Crossfire® 异心插入件10°；Artisan® 骨塞；UHR® 通用头双极组件Howmedica Osteonics Corp., Dba Stryker Orthopaedics K243192iNSitu 侧向髋臼衬垫，iNSitu 带等离子喷涂 CPTi 涂层的股骨柄Nextstep Arthopedix, LLC K251270Taperloc® 完整髋臼柄Biomet, Inc.

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。