FDA 510(k)

PERMALOOP 缝线，PERMATAPE 缝线

K号: K220219 · 2022-04-26

决定日期2022-04-26

产品代码GAT

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

PERMALOOP Suture, PERMATAPE Suture 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 2022-04-26 under 510(k) number K220219. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PERMALOOP Suture, PERMATAPE Suture?

PERMALOOP Suture, PERMATAPE Suture is a medical device that received FDA 510(k) clearance on 2022-04-26. The listed applicant is Medos International SARL. The 510(k) number is K220219.

When did PERMALOOP Suture, PERMATAPE Suture receive FDA 510(k) clearance?

PERMALOOP Suture, PERMATAPE Suture received FDA 510(k) clearance on 2022-04-26, under 510(k) number K220219.

Who is the listed applicant for PERMALOOP Suture, PERMATAPE Suture?

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 PERMALOOP Suture, PERMATAPE Suture?

The FDA product code for PERMALOOP Suture, PERMATAPE Suture is GAT.

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。