My3D® 个性化骨盆重建設備
K 號：K212815 · 2022-07-06
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器材摘要
My3D® Personalized Pelvic Reconstruction is the device name listed in this FDA 510(k) record. The listed applicant is Onkos Surgical. It received FDA 510(k) clearance on 2022-07-06 under 510(k) number K212815. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the My3D® Personalized Pelvic Reconstruction?
My3D® Personalized Pelvic Reconstruction is a medical device that received FDA 510(k) clearance on 2022-07-06. The listed applicant is Onkos Surgical. The 510(k) number is K212815.
When did My3D® Personalized Pelvic Reconstruction receive FDA 510(k) clearance?
My3D® Personalized Pelvic Reconstruction received FDA 510(k) clearance on 2022-07-06, under 510(k) number K212815.
Who is the listed applicant for My3D® Personalized Pelvic Reconstruction?
The FDA 510(k) record lists Onkos Surgical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for My3D® Personalized Pelvic Reconstruction?
The FDA product code for My3D® Personalized Pelvic Reconstruction is LPH.
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。
其他以 Onkos Surgical 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：LPH）
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。
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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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