FDA 510(k)

TekBrace 獨立軟組織強化設備

K 號：K261621 · 2026-06-09

決定日期2026-06-09

產品代碼QUW

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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) 記錄將Theramicro列為申請人。這並不單獨確立設備製造商。

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.

其他以 Theramicro 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262729TeKBrace獨立軟組織加固設備 K253538TeKBrace 非節結固定針 K251063TekBrace 獨立軟組織強化設備

相關器械（代碼：QUW）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262729TeKBrace獨立軟組織加固設備Theramicro K242237Jewel軟組織加固設備（102-6005）Xiros Limited K251063TekBrace 獨立軟組織強化設備Theramicro K222978多膠帶/無限鎖軟組織加固裝置Xiros, Ltd.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。