FDA 510(k)

MectaLIF 3D金屬前臍

K 號：K254202 · 2026-05-05

決定日期2026-05-05

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

MectaLIF 3D Metal Anterior 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 2026-05-05 under 510(k) number K254202. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MectaLIF 3D Metal Anterior?

MectaLIF 3D Metal Anterior is a medical device that received FDA 510(k) clearance on 2026-05-05. The listed applicant is Medacta International S.A.. The 510(k) number is K254202.

When did MectaLIF 3D Metal Anterior receive FDA 510(k) clearance?

MectaLIF 3D Metal Anterior received FDA 510(k) clearance on 2026-05-05, under 510(k) number K254202.

Who is the listed applicant for MectaLIF 3D Metal Anterior?

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 MectaLIF 3D Metal Anterior?

The FDA product code for MectaLIF 3D Metal Anterior is OVD.

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 K253940M.U.S.T. 椎板螺釘系統 - 延伸版 K253328GMK 3D金屬胫骨托延伸器 K250644MSS - 单塊樹枝 K251043Mpact 3D金屬植入物擴充 – DMLS技術

查看所有 148 項裝置 →

相關器械（代碼：OVD）

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。

K262025Innovasis AxTiHA® 独立式 ALIF 系統；Innovasis TxTiHA® IBF 系統；Innovasis HAtetracell®-C 鈦金屬頸椎 IBF 系統INNO Holdings Inc. DBA Innovasis K261408SABER-XA 系統Elevation Spine K261809Interwedge® 独立側邊架Foundation Surgical Group K261353泰瑟拉-K 前腰椎間融合（ALIF）系統；泰瑟拉-K XL 系統；腰椎固定系統Kyocera Medical Technologies, Inc.K260810Anteralign LS 盖板Tyber Medical, LLC K253401SCRIPT™ 嵌入系統Globus Medical, Inc.

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。