FDA 510(k)

智能空間肩部系統

K 號：K202454 · 2020-12-28

決定日期2020-12-28

產品代碼QHE

諮詢委員會或

決定相當於

器材摘要

Smart SPACE Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Techmah Medical, LLC. It received FDA 510(k) clearance on 2020-12-28 under 510(k) number K202454. 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 System?

Smart SPACE Shoulder System is a medical device that received FDA 510(k) clearance on 2020-12-28. The listed applicant is Techmah Medical, LLC. The 510(k) number is K202454.

When did Smart SPACE Shoulder System receive FDA 510(k) clearance?

Smart SPACE Shoulder System received FDA 510(k) clearance on 2020-12-28, under 510(k) number K202454.

Who is the listed applicant for Smart SPACE Shoulder System?

The FDA 510(k) record lists Techmah Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart SPACE Shoulder System?

The FDA product code for Smart SPACE Shoulder System is QHE.

其他以 Techmah Medical, LLC 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。

K202151智能空間肩部系統 K191247SmartSPACE 肩部系統

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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