FDA 510(k)

Catalyst R1反向肩关节系统

K号: K211991 · 2021-07-28

决定日期2021-07-28

产品代码PHX

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

Catalyst R1 Reverse Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Catalyst Orthoscience, Inc.. It received FDA 510(k) clearance on 2021-07-28 under 510(k) number K211991. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Catalyst R1 Reverse Shoulder System?

Catalyst R1 Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2021-07-28. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K211991.

When did Catalyst R1 Reverse Shoulder System receive FDA 510(k) clearance?

Catalyst R1 Reverse Shoulder System received FDA 510(k) clearance on 2021-07-28, under 510(k) number K211991.

Who is the listed applicant for Catalyst R1 Reverse Shoulder System?

The FDA 510(k) record lists Catalyst Orthoscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Catalyst R1 Reverse Shoulder System?

The FDA product code for Catalyst R1 Reverse Shoulder System is PHX.

列明Catalyst Orthoscience, Inc.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。

K252418Catalyst F1x肩关节系统 K234105Catalyst F1x肩关节系统 K232583Catalyst R1反向肩关节系统 K223655Catalyst R1反向肩关节系统 K222317Catalyst EA可转换肩关节假体 K213349Catalyst R1反向肩关节系统

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