FDA 510(k)

正骨科Next平台系統

K 號：K242270 · 2024-12-19

決定日期2024-12-19

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

OrthoNext Platform System is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K242270. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OrthoNext Platform System?

OrthoNext Platform System is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Orthofix Srl. The 510(k) number is K242270.

When did OrthoNext Platform System receive FDA 510(k) clearance?

OrthoNext Platform System received FDA 510(k) clearance on 2024-12-19, under 510(k) number K242270.

Who is the listed applicant for OrthoNext Platform System?

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

What is the FDA product code for OrthoNext Platform System?

The FDA product code for OrthoNext Platform System is QIH.

其他以 Orthofix Srl 為申請人之記錄

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相關器械（代碼：QIH）

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。

K260055syngo.CT 脑量化Siemens Medical Solutions USA, Inc.K262390骨專家Visiana K261368快速平台（R6.7）Ischemaview, Inc.K261623EchoPAC 軟體僅 / EchoPAC 插件（v211）GE Medical Systems Ultrasound and Primary Care Diagnostics K261677人工智慧腎臟評估（AIRA）版本 1Aramis Global AI Consultancies, LLC K2608794DMINVIA, LLC

官方來源

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