FDA 510(k)

Poly-Tape/Infinity-Lock 软组织加固装置

K号: K222978 · 2022-12-27

决定日期2022-12-27

产品代码QUW

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决定实质等同

器械摘要

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is the device name listed in this FDA 510(k) record. The listed applicant is Xiros, Ltd.. It received FDA 510(k) clearance on 2022-12-27 under 510(k) number K222978. The device is classified under product code QUW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device?

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is a medical device that received FDA 510(k) clearance on 2022-12-27. The listed applicant is Xiros, Ltd.. The 510(k) number is K222978.

When did Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device receive FDA 510(k) clearance?

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device received FDA 510(k) clearance on 2022-12-27, under 510(k) number K222978.

Who is the listed applicant for Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device?

The FDA 510(k) record lists Xiros, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device?

The FDA product code for Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is QUW.

列明Xiros, Ltd.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。

K230671Pitch PaSoft 软组织加固设备 K220091Poly-Tape/Infinity-Lock 软组织加固装置 K220906SECURE-LOCK K211563Pitch-Patchs K191053Xtreme-Loop K180243Infinity-Lock Button System

查看所有 8 个设备 →

官方来源

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