ROSA 適合膝關節系統搭配超聲影像平台（USIP）
K 號：K252058 · 2026-02-06
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器材摘要
ROSA Knee System with UltraSound Imaging Platform (USIP) is the device name listed in this FDA 510(k) record. The listed applicant is Balmoral Medical, LLC. It received FDA 510(k) clearance on 2026-02-06 under 510(k) number K252058. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ROSA Knee System with UltraSound Imaging Platform (USIP)?
ROSA Knee System with UltraSound Imaging Platform (USIP) is a medical device that received FDA 510(k) clearance on 2026-02-06. The listed applicant is Balmoral Medical, LLC. The 510(k) number is K252058.
When did ROSA Knee System with UltraSound Imaging Platform (USIP) receive FDA 510(k) clearance?
ROSA Knee System with UltraSound Imaging Platform (USIP) received FDA 510(k) clearance on 2026-02-06, under 510(k) number K252058.
Who is the listed applicant for ROSA Knee System with UltraSound Imaging Platform (USIP)?
The FDA 510(k) record lists Balmoral Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ROSA Knee System with UltraSound Imaging Platform (USIP)?
The FDA product code for ROSA Knee System with UltraSound Imaging Platform (USIP) is OLO.
相關臨床試驗
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。
相關器械（代碼：OLO）
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。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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