FDA 510(k)

TekBrace 单软组织加固设备

K号: K261621 · 2026-06-09

决定日期2026-06-09

产品代码QUW

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决定实质等同

器械摘要

TekBrace Solo Soft Tissue Reinforcement Device is the device name listed in this FDA 510(k) record. The listed applicant is Theramicro. It received FDA 510(k) clearance on 2026-06-09 under 510(k) number K261621. 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 TekBrace Solo Soft Tissue Reinforcement Device?

TekBrace Solo Soft Tissue Reinforcement Device is a medical device that received FDA 510(k) clearance on 2026-06-09. The listed applicant is Theramicro. The 510(k) number is K261621.

When did TekBrace Solo Soft Tissue Reinforcement Device receive FDA 510(k) clearance?

TekBrace Solo Soft Tissue Reinforcement Device received FDA 510(k) clearance on 2026-06-09, under 510(k) number K261621.

Who is the listed applicant for TekBrace Solo Soft Tissue Reinforcement Device?

FDA 510(k)记录将Theramicro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 TekBrace Solo Soft Tissue Reinforcement Device?

The FDA product code for TekBrace Solo Soft Tissue Reinforcement Device is QUW.

列明Theramicro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。

K262729TeKBrace 独立软组织加固装置 K253538TeKBrace 无结锚 K251063TekBrace 单软组织加固设备

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。