FDA 510(k)

TeKBrace 非節結固定針

K 號：K253538 · 2026-03-06

決定日期2026-03-06

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

TeKBrace Knotless Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Theramicro. It received FDA 510(k) clearance on 2026-03-06 under 510(k) number K253538. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TeKBrace Knotless Anchor?

TeKBrace Knotless Anchor is a medical device that received FDA 510(k) clearance on 2026-03-06. The listed applicant is Theramicro. The 510(k) number is K253538.

When did TeKBrace Knotless Anchor receive FDA 510(k) clearance?

TeKBrace Knotless Anchor received FDA 510(k) clearance on 2026-03-06, under 510(k) number K253538.

Who is the listed applicant for TeKBrace Knotless Anchor?

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 Knotless Anchor?

The FDA product code for TeKBrace Knotless Anchor is MBI.

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。

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相關器械（代碼：MBI）

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。

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官方來源

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