FDA 510(k)

MILAGRO 交錯螺釘；MILAGRO ADVANCE 交錯螺釘

K 號：K240441 · 2024-03-15

決定日期2024-03-15

產品代碼MAI

諮詢委員會或

決定相當於

器材摘要

MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek. It received FDA 510(k) clearance on 2024-03-15 under 510(k) number K240441. 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 MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw?

MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Depuy Mitek. The 510(k) number is K240441.

When did MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw receive FDA 510(k) clearance?

MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw received FDA 510(k) clearance on 2024-03-15, under 510(k) number K240441.

Who is the listed applicant for MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw?

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 MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw?

The FDA product code for MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw is MAI.

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 K241010HEALIX ADVANCE 非結節釘；HEALIX ADVANCE 自擊釘

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。

K262357Arthrex 生物可吸收式 PushLock 縫線釘Arthrex, Inc.K253931Arthrex 生物可吸收式 PushLock 縫線釘Arthrex, Inc.K260294SF 推入式固定釘Surgical Fusion Technologies GmbH K254055OSSIOfiber® 緝線墊板OSSIO , Ltd.K251680Biosteon® 螺釘Biocomposites, Ltd.K252946BioBrace® 間節韌帶增強組合Conmed Corporation

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。