FDA 510(k)

Libertas髋关节假体罩

K号: K183365 · 2019-02-22

决定日期2019-02-22

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

Libertas Acetabular Hooded Liner is the device name listed in this FDA 510(k) record. The listed applicant is Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-02-22 under 510(k) number K183365. 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 Libertas Acetabular Hooded Liner?

Libertas Acetabular Hooded Liner is a medical device that received FDA 510(k) clearance on 2019-02-22. The listed applicant is Maxx Orthopedics, Inc.. The 510(k) number is K183365.

When did Libertas Acetabular Hooded Liner receive FDA 510(k) clearance?

Libertas Acetabular Hooded Liner received FDA 510(k) clearance on 2019-02-22, under 510(k) number K183365.

Who is the listed applicant for Libertas Acetabular Hooded Liner?

FDA 510(k)记录将Maxx Orthopedics, Inc.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Libertas Acetabular Hooded Liner?

The FDA product code for Libertas Acetabular Hooded Liner is LZO.

列明Maxx Orthopedics, 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。

K261563Freedom 全膝关节系统（E-Poly 股骨远端衬垫）K261609自由部分膝关节系统 K253171Libertas锥形短（TS）非骨水泥股骨柄（Libertas TS柄）K252777Freedom干骺端锥形植入物（干骺端锥）K253314Freedom Infinia®全膝关节系统 K253144Freedom® 全膝关节系统 – Titan PCK 组件

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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。