FDA 510(k)

獵鷹縫合墊

K 號：K243726 · 2025-01-30

決定日期2025-01-30

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Osprey Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Responsive Arthroscopy, Inc.. It received FDA 510(k) clearance on 2025-01-30 under 510(k) number K243726. 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 Osprey Suture Anchor?

Osprey Suture Anchor is a medical device that received FDA 510(k) clearance on 2025-01-30. The listed applicant is Responsive Arthroscopy, Inc.. The 510(k) number is K243726.

When did Osprey Suture Anchor receive FDA 510(k) clearance?

Osprey Suture Anchor received FDA 510(k) clearance on 2025-01-30, under 510(k) number K243726.

Who is the listed applicant for Osprey Suture Anchor?

FDA 510(k) 記錄將 Responsive Arthroscopy, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Osprey Suture Anchor?

The FDA product code for Osprey Suture Anchor is MBI.

其他以 Responsive Arthroscopy, Inc. 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。

K261632雷霆系統

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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