FDA 510(k)

特里登II髋臼系统

K号: K191358 · 2019-10-24

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

决定日期2019-10-24

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 Acetabular System 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 2019-10-24 under 510(k) number K191358. 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 Acetabular System?

Trident II Acetabular System is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K191358.

When did Trident II Acetabular System receive FDA 510(k) clearance?

Trident II Acetabular System received FDA 510(k) clearance on 2019-10-24, under 510(k) number K191358.

Who is the listed applicant for Trident II Acetabular System?

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 Acetabular System?

The FDA product code for Trident II Acetabular System is LPH.