Mako 全膝應用
K 號：K220459 · 2022-04-15
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器材摘要
Mako Total Knee Application is the device name listed in this FDA 510(k) record. The listed applicant is Mako Surgical Corp.. It received FDA 510(k) clearance on 2022-04-15 under 510(k) number K220459. 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 Mako Total Knee Application?
Mako Total Knee Application is a medical device that received FDA 510(k) clearance on 2022-04-15. The listed applicant is Mako Surgical Corp.. The 510(k) number is K220459.
When did Mako Total Knee Application receive FDA 510(k) clearance?
Mako Total Knee Application received FDA 510(k) clearance on 2022-04-15, under 510(k) number K220459.
Who is the listed applicant for Mako Total Knee Application?
The FDA 510(k) record lists Mako Surgical Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Mako Total Knee Application?
The FDA product code for Mako Total Knee Application is OLO.
相關臨床試驗
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其他以 Mako Surgical Corp. 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。
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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