FDA 510(k)

OC 無節結環環柔軟锚；OC 無節環柔軟锚

K 號：K243203 · 2024-10-29

決定日期2024-10-29

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

OC JuggerKnotless Soft Anchor; OC JuggerLoop 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 2024-10-29 under 510(k) number K243203. 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 JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor?

OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is Riverpoint Medical. The 510(k) number is K243203.

When did OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor receive FDA 510(k) clearance?

OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor received FDA 510(k) clearance on 2024-10-29, under 510(k) number K243203.

Who is the listed applicant for OC JuggerKnotless Soft Anchor; OC JuggerLoop 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 JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor?

The FDA product code for OC JuggerKnotless Soft Anchor; OC JuggerLoop 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 K241282RibFix Titan™ 固定系統

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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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