正骨科MI系統
K 號：K211992 · 2021-10-15
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器材摘要
Ortho MI System is the device name listed in this FDA 510(k) record. The listed applicant is Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2021-10-15 under 510(k) number K211992. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Ortho MI System?
Ortho MI System is a medical device that received FDA 510(k) clearance on 2021-10-15. The listed applicant is Osteonic Co., Ltd.. The 510(k) number is K211992.
When did Ortho MI System receive FDA 510(k) clearance?
Ortho MI System received FDA 510(k) clearance on 2021-10-15, under 510(k) number K211992.
Who is the listed applicant for Ortho MI System?
The FDA 510(k) record lists Osteonic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ortho MI System?
The FDA product code for Ortho MI System is OAT.
相關臨床試驗
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其他以 Osteonic Co., Ltd. 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：OAT）
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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