FDA 510(k)

Corin 优化定位系统功能髋关节分析 (OPS FHA)

K号: K190834 · 2019-07-22

决定日期2019-07-22

产品代码LZO

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

Corin Optimized Position System Functional Hip Analysis (OPS FHA) is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2019-07-22 under 510(k) number K190834. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Corin Optimized Position System Functional Hip Analysis (OPS FHA)?

Corin Optimized Position System Functional Hip Analysis (OPS FHA) is a medical device that received FDA 510(k) clearance on 2019-07-22. The listed applicant is Corin USA. The 510(k) number is K190834.

When did Corin Optimized Position System Functional Hip Analysis (OPS FHA) receive FDA 510(k) clearance?

Corin Optimized Position System Functional Hip Analysis (OPS FHA) received FDA 510(k) clearance on 2019-07-22, under 510(k) number K190834.

Who is the listed applicant for Corin Optimized Position System Functional Hip Analysis (OPS FHA)?

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

What is the FDA product code for Corin Optimized Position System Functional Hip Analysis (OPS FHA)?

The FDA product code for Corin Optimized Position System Functional Hip Analysis (OPS FHA) is LZO.

列明Corin USA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。

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官方来源

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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。