FDA 510(k)

Materialise Shoulder System™ 材質化肩關節系統 Materialise Shoulder Guide 和模型 SurgiCase Shoulder 规劃器

K 號：K220452 · 2022-08-17

決定日期2022-08-17

產品代碼QHE

諮詢委員會或

決定相當於

器材摘要

Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2022-08-17 under 510(k) number K220452. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner?

Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner is a medical device that received FDA 510(k) clearance on 2022-08-17. The listed applicant is Materialise NV. The 510(k) number is K220452.

When did Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner receive FDA 510(k) clearance?

Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner received FDA 510(k) clearance on 2022-08-17, under 510(k) number K220452.

Who is the listed applicant for Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner?

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 Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner?

The FDA product code for Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner is QHE.

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 K243637Materialise個人化頭顱顏面手術導引和模型

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相關器械（代碼：QHE）

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 PlannerMaterialise NV K261510Signature™ ONE 系統Orthosoft Inc. (d/b/a) Zimmer CAS K260104Signature™ ONE 系統Orthosoft Inc. (d/b/a) Zimmer CAS K251558精準人工智慧外科計劃系統（PAI-SPS）Precision AI Pty, Ltd.K243509Archer PSI 系統3D-Side K241470核心肩部系統LinkBio Corp.

官方來源

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