FDA 510(k)

AltiVate反向肱骨柄，48mm

K号: K190290 · 2019-04-26

决定日期2019-04-26

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 Reverse Humeral Stem, 48mm 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 2019-04-26 under 510(k) number K190290. 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 Reverse Humeral Stem, 48mm?

AltiVate Reverse Humeral Stem, 48mm is a medical device that received FDA 510(k) clearance on 2019-04-26. The listed applicant is Encore Medical L.P.. The 510(k) number is K190290.

When did AltiVate Reverse Humeral Stem, 48mm receive FDA 510(k) clearance?

AltiVate Reverse Humeral Stem, 48mm received FDA 510(k) clearance on 2019-04-26, under 510(k) number K190290.

Who is the listed applicant for AltiVate Reverse Humeral Stem, 48mm?

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 Reverse Humeral Stem, 48mm?

The FDA product code for AltiVate Reverse Humeral Stem, 48mm 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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