FDA 510(k)

智能空間肩部計劃儀及3D定位器

K 號：K222405 · 2022-12-20

決定日期2022-12-20

產品代碼QHE

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決定相當於

器材摘要

Smart SPACE Shoulder Planner and 3D Positioners is the device name listed in this FDA 510(k) record. The listed applicant is Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2022-12-20 under 510(k) number K222405. 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 Smart SPACE Shoulder Planner and 3D Positioners?

Smart SPACE Shoulder Planner and 3D Positioners is a medical device that received FDA 510(k) clearance on 2022-12-20. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K222405.

When did Smart SPACE Shoulder Planner and 3D Positioners receive FDA 510(k) clearance?

Smart SPACE Shoulder Planner and 3D Positioners received FDA 510(k) clearance on 2022-12-20, under 510(k) number K222405.

Who is the listed applicant for Smart SPACE Shoulder Planner and 3D Positioners?

The FDA 510(k) record lists Lima Corporate S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart SPACE Shoulder Planner and 3D Positioners?

The FDA product code for Smart SPACE Shoulder Planner and 3D Positioners is QHE.

其他以 Lima Corporate S.P.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。

K252352SMR肩關節系統；PRIMA關節盂系統；PRIMA肱骨系統 K251718ArTT 增強與支撐及骨釘 K243826SMR逆向高壓肩關節系統 K250980Physica 系統（Physica CR 多孔股骨组件）K243615物理多孔股骨组件 K234011AMF TT Cones

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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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