FDA 510(k)

迷你超鷹縫合釘系統

K 號：K253010 · 2025-10-14

決定日期2025-10-14

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Mini Superhawk Suture Anchor System is the device name listed in this FDA 510(k) record. The listed applicant is Responsive Arthroscopy, LLC. It received FDA 510(k) clearance on 2025-10-14 under 510(k) number K253010. 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 Mini Superhawk Suture Anchor System?

Mini Superhawk Suture Anchor System is a medical device that received FDA 510(k) clearance on 2025-10-14. The listed applicant is Responsive Arthroscopy, LLC. The 510(k) number is K253010.

When did Mini Superhawk Suture Anchor System receive FDA 510(k) clearance?

Mini Superhawk Suture Anchor System received FDA 510(k) clearance on 2025-10-14, under 510(k) number K253010.

Who is the listed applicant for Mini Superhawk Suture Anchor System?

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

What is the FDA product code for Mini Superhawk Suture Anchor System?

The FDA product code for Mini Superhawk Suture Anchor System is MBI.

其他以 Responsive Arthroscopy, LLC 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。

K261869整潔式可收回式植入器插入器（6000127）Anika Therapeutics, Inc.K253065Aevumed SUPERCYNCH™按鈕系統Aevumed, Inc.K262809ArthroTAK 軟骨組織锚定組合包ArthroTAK, LLC K262677Iconix Knotless TRiverpoint Medical K262047Grappler縫合釘系統Paragon 28, Inc.K262369AIR+ 全內側半月板修復設備，向上曲；AIR+ 全內側半月板修復設備，向下曲Stryker Endoscopy

官方來源

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