FDA 510(k)

GRYPHON™ X 牙根固定器；HEALIX TRANSTEND™ 牙根固定器

K 號：K243790 · 2025-02-05

決定日期2025-02-05

產品代碼MAI

諮詢委員會或

決定相當於

器材摘要

GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek. It received FDA 510(k) clearance on 2025-02-05 under 510(k) number K243790. 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 GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor?

GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor is a medical device that received FDA 510(k) clearance on 2025-02-05. The listed applicant is Depuy Mitek. The 510(k) number is K243790.

When did GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor receive FDA 510(k) clearance?

GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor received FDA 510(k) clearance on 2025-02-05, under 510(k) number K243790.

Who is the listed applicant for GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor?

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 GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor?

The FDA product code for GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor 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。

K241010HEALIX ADVANCE 非結節釘；HEALIX ADVANCE 自擊釘 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。

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

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