FDA 510(k)

GMK 3D金屬胫骨托延伸器

K 號：K253328 · 2026-02-26

決定日期2026-02-26

產品代碼MBH

諮詢委員會或

決定相當於

器材摘要

GMK 3D Metal Tibial Tray Extension is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2026-02-26 under 510(k) number K253328. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GMK 3D Metal Tibial Tray Extension?

GMK 3D Metal Tibial Tray Extension is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is Medacta International S.A.. The 510(k) number is K253328.

When did GMK 3D Metal Tibial Tray Extension receive FDA 510(k) clearance?

GMK 3D Metal Tibial Tray Extension received FDA 510(k) clearance on 2026-02-26, under 510(k) number K253328.

Who is the listed applicant for GMK 3D Metal Tibial Tray Extension?

FDA 510(k) 記錄將 Medacta International S.A. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for GMK 3D Metal Tibial Tray Extension?

The FDA product code for GMK 3D Metal Tibial Tray Extension is MBH.

其他以 Medacta International S.A. 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。

K260173M-Vizion 髋關節更換系統擴充版 K253630Mpact 3D金屬泡沫 K254202MectaLIF 3D金屬前臍 K253940M.U.S.T. 椎板螺釘系統 - 延伸版 K250644MSS - 单塊樹枝 K251043Mpact 3D金屬植入物擴充 – DMLS技術

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相關器械（代碼：MBH）

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。

K261275Unity全膝系統，Unity膝水泥無縫股骨Corin, Ltd.K261462LANDMARK 全膝系統Smith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® 道骨系統Microport Orthopedics, Inc.K251840齊默® 佩森娜® 適合個人化膝關節系統Zimmer, Inc.K253189Persona 個人化膝關節系統（Persona 多孔等离子喷涂 PPS 髋骨）Zimmer, Inc.K253637Triathlon® 全膝系統 - Triathlon® X3® 中間穩定胫骨承插件Howmedica Osteonics Corp., Dba Stryker Orthopaedics

官方來源

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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。