FDA 510(k)

EXPEDIUM® 脊柱系统，EXPEDIUM VERSE® 脊柱系统：ALTALYNE™ 超级杆

K号: K222473 · 2022-10-13

决定日期2022-10-13

产品代码NKB

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

EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods is the device name listed in this FDA 510(k) record. The listed applicant is Medos-International Sarl. It received FDA 510(k) clearance on 2022-10-13 under 510(k) number K222473. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods?

EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods is a medical device that received FDA 510(k) clearance on 2022-10-13. The listed applicant is Medos-International Sarl. The 510(k) number is K222473.

When did EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods receive FDA 510(k) clearance?

EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods received FDA 510(k) clearance on 2022-10-13, under 510(k) number K222473.

Who is the listed applicant for EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods?

The FDA 510(k) record lists Medos-International Sarl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods?

The FDA product code for EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods is NKB.

列明Medos-International Sarl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。

K254157CROSSNAV 导航启用工具用于椎间盘准备和椎间 K260240SYMPHONY Navigation Ready Instruments K253249TriALTIS™ 脊柱系统 K243249TriALTIS™ 脊柱系统 K241893CROSSNAV 导航启用工具和UNAS 导航阵列 K242042TriALTIS™ 脊柱系统

查看所有 75 个设备 →

官方来源

在 FDA 数据库中查看 →

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。