FDA 510(k)

無縫縫合釘

K 號：K231278 · 2023-08-01

決定日期2023-08-01

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Knotless Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Riverpoint Medical, LLC. It received FDA 510(k) clearance on 2023-08-01 under 510(k) number K231278. 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 Knotless Suture Anchor?

Knotless Suture Anchor is a medical device that received FDA 510(k) clearance on 2023-08-01. The listed applicant is Riverpoint Medical, LLC. The 510(k) number is K231278.

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

Knotless Suture Anchor received FDA 510(k) clearance on 2023-08-01, under 510(k) number K231278.

Who is the listed applicant for Knotless Suture Anchor?

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

What is the FDA product code for Knotless Suture Anchor?

The FDA product code for Knotless Suture Anchor is MBI.

其他以 Riverpoint Medical, 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。

K253693Strut 綁線；無結按鈕 K253695LigaMend K243988RootMend MRR K242494OsseoFit 接口樁；OsseoFit 骨隧道結構 K232411JuggerKnot 轟結軟性固定器 OC K231078All-Suture Anchor

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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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