FDA 510(k)

OC 鋼絲結節軟性固定器

K 號：K240719 · 2024-04-11

決定日期2024-04-11

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

OC JuggerKnot Soft Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Riverpoint Medical. It received FDA 510(k) clearance on 2024-04-11 under 510(k) number K240719. 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 OC JuggerKnot Soft Anchor?

OC JuggerKnot Soft Anchor is a medical device that received FDA 510(k) clearance on 2024-04-11. The listed applicant is Riverpoint Medical. The 510(k) number is K240719.

When did OC JuggerKnot Soft Anchor receive FDA 510(k) clearance?

OC JuggerKnot Soft Anchor received FDA 510(k) clearance on 2024-04-11, under 510(k) number K240719.

Who is the listed applicant for OC JuggerKnot Soft Anchor?

FDA 510(k) 記錄將 Riverpoint Medical 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for OC JuggerKnot Soft Anchor?

The FDA product code for OC JuggerKnot Soft Anchor is MBI.

其他以 Riverpoint Medical 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。

K262677Iconix Knotless T K253024ProZip 齊結式植入體 K252201HS纖維 K252144Iconix Speed Anchor；Iconix Speed HA+ Anchor K243323Iconix無縫錨 K243203OC 無節結環環柔軟锚；OC 無節環柔軟锚

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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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