FDA 510(k)

AltiVate®带标记的解剖性肩部AG e+™

K号: K213387 · 2022-07-07

决定日期2022-07-07

产品代码KWS

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

AltiVate® Anatomic Shoulder AG e+™ with Markers is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2022-07-07 under 510(k) number K213387. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AltiVate® Anatomic Shoulder AG e+™ with Markers?

AltiVate® Anatomic Shoulder AG e+™ with Markers is a medical device that received FDA 510(k) clearance on 2022-07-07. The listed applicant is Encore Medical L.P.. The 510(k) number is K213387.

When did AltiVate® Anatomic Shoulder AG e+™ with Markers receive FDA 510(k) clearance?

AltiVate® Anatomic Shoulder AG e+™ with Markers received FDA 510(k) clearance on 2022-07-07, under 510(k) number K213387.

Who is the listed applicant for AltiVate® Anatomic Shoulder AG e+™ with Markers?

The FDA 510(k) record lists Encore Medical L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AltiVate® Anatomic Shoulder AG e+™ with Markers?

The FDA product code for AltiVate® Anatomic Shoulder AG e+™ with Markers is KWS.

列明Encore Medical L.P.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。

K252567AltiVate Reverse® ADLC球窝 K252974EMPOWR 膝关节 K251833EMPOWR 髋臼® 线条延长 K252141AltiVate Reverse®肩胛骨 K251776EMPOWR翻修膝关节™ (EMPOWR翻修VVC+，e+胫骨植入物)K251241EMPOWR翻修膝关节™ (EMPOWR翻修膝关节™ 对称TT锥)

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官方来源

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