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FDA 510(k)

HEALIX ADVANCE 非結節釘；HEALIX ADVANCE 自擊釘

K 號：K241010 · 2024-09-11

申請人Depuy Mitek
決定日期2024-09-11
產品代碼MAI
諮詢委員會或
決定相當於

器材摘要

HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek. It received FDA 510(k) clearance on 2024-09-11 under 510(k) number K241010. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors?

HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors is a medical device that received FDA 510(k) clearance on 2024-09-11. The listed applicant is Depuy Mitek. The 510(k) number is K241010.

When did HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors receive FDA 510(k) clearance?

HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors received FDA 510(k) clearance on 2024-09-11, under 510(k) number K241010.

Who is the listed applicant for HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors?

The FDA 510(k) record lists Depuy Mitek as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors?

The FDA product code for HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors is MAI.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Depuy Mitek 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。

K243790GRYPHON™ X 牙根固定器；HEALIX TRANSTEND™ 牙根固定器K240441MILAGRO 交錯螺釘；MILAGRO ADVANCE 交錯螺釘

相關器械（代碼：MAI）

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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