FDA 510(k)

預縫合腱

K 號：K253145 · 2025-10-22

決定日期2025-10-22

產品代碼GAT

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

Pre-Sutured Tendon is the device name listed in this FDA 510(k) record. The listed applicant is Rti Surgical, Inc.. It received FDA 510(k) clearance on 2025-10-22 under 510(k) number K253145. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pre-Sutured Tendon?

Pre-Sutured Tendon is a medical device that received FDA 510(k) clearance on 2025-10-22. The listed applicant is Rti Surgical, Inc.. The 510(k) number is K253145.

When did Pre-Sutured Tendon receive FDA 510(k) clearance?

Pre-Sutured Tendon received FDA 510(k) clearance on 2025-10-22, under 510(k) number K253145.

Who is the listed applicant for Pre-Sutured Tendon?

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

What is the FDA product code for Pre-Sutured Tendon?

The FDA product code for Pre-Sutured Tendon is GAT.

其他以 Rti Surgical, Inc. 為申請人之記錄

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相關器械（代碼：GAT）

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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