FDA 510(k)

Aevumed FASE 縫線锚

K 號：K253040 · 2025-10-21

決定日期2025-10-21

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Aevumed FASE Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Aevumed, Inc.. It received FDA 510(k) clearance on 2025-10-21 under 510(k) number K253040. 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 Aevumed FASE Suture Anchor?

Aevumed FASE Suture Anchor is a medical device that received FDA 510(k) clearance on 2025-10-21. The listed applicant is Aevumed, Inc.. The 510(k) number is K253040.

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

Aevumed FASE Suture Anchor received FDA 510(k) clearance on 2025-10-21, under 510(k) number K253040.

Who is the listed applicant for Aevumed FASE Suture Anchor?

FDA 510(k) 記錄將 Aevumed, 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 Aevumed FASE Suture Anchor?

The FDA product code for Aevumed FASE Suture Anchor is MBI.

其他以 Aevumed, 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。

K253065Aevumed SUPERCYNCH™按鈕系統 K254306Aevumed FENIX 縫線锚 K260004Aevumed PROTEKT 緝合釘 K242895Aevumed PHANTOM 縫線锚 K223878Aevumed RAPID 緝合釘 K222363Aevumed PHANTOM™-LP 縫線锚

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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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