FDA 510(k)

Materialise個人化頭顱顏面手術導引和模型

K 號：K243637 · 2025-02-21

決定日期2025-02-21

產品代碼DZJ

諮詢委員會DE

決定相當於

器材摘要

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2025-02-21 under 510(k) number K243637. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Materialise Personalized Guides and Models for Craniomaxillofacial Surgery?

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery is a medical device that received FDA 510(k) clearance on 2025-02-21. The listed applicant is Materialise NV. The 510(k) number is K243637.

When did Materialise Personalized Guides and Models for Craniomaxillofacial Surgery receive FDA 510(k) clearance?

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery received FDA 510(k) clearance on 2025-02-21, under 510(k) number K243637.

Who is the listed applicant for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery?

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

What is the FDA product code for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery?

The FDA product code for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery is DZJ.

其他以 Materialise NV 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。

K260802Materialise Shoulder System™，Materialise Shoulder Guide 及 Model，SurgiCase Shoulder Planner K251964模擬胸腔計劃器 K253308Materialise 頭顎面外科手術個人化導引和模型 CMF 鋼钛導引；CMF 塑膠模型 K253793Materialise 骨關節置换導引系統 K251554Materialise 骨關節置换導引系統 K242813Materialise Shoulder System™，Materialise Shoulder Guide 及 Model，SurgiCase Shoulder Planner

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相關器械（代碼：DZJ）

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。

K261826VSP系統（鈦金顎板牙橋）3D Systems, Inc.K242263TECHFIT DISRP® 系統Techfit Digital Surgery, Inc.K231520tmCMF解決方案Techmah Cmf K230276TECHFIT DISRP® 系統Techfit Digital Surgery K223024MedCAD精準計劃系統Medcad K220366嵌入式醫療設備3D Lifeprints UK , Ltd.

官方來源

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