Translational research of one dynamic hip screw system | 合法醫療器材資訊網
由HCKao著作·2016—TheOrthopaedicDeviceResearchCenterdynamichipscrewsystem(ODRC-DHSsystem),whichwasdevelopedbytheODRC,National ...
Background/objective: When researchers or developers wish to apply their findings to clinical usages, it must be approved by public authorities such as the US Food and Drug Administration (FDA). In addition to the development records and risk control documents, all of the materials and testing must be completed by laboratories or manufacturers with good quality controls in accordance with related regulations or standards. The Orthopaedic Device Research Center dynamic hip screw system (ODRC-DHS system), which was developed by the ODRC, National Yang-Ming University, Taipei, Taiwan, obtained FDA 510(k) clearance in 2011.
Methods: The application process was divided into five steps: (1) make sure that the product is a medical device and classify it; (2) find the predicate devices cleared by the FDA; (3) research any standards and/or guidance documents; (4) prepare the appropriate information for prema...
華骨-髖骨板系統 | 合法醫療器材資訊網
未命名頁面 | 合法醫療器材資訊網
The schematic diagram of the ODRC dynamic hip screw ... | 合法醫療器材資訊網
(a) Blade Screw DHS (ODRC Dynamic Hip Screw System ... | 合法醫療器材資訊網
(PDF) Translational research of a dynamic hip screw system ... | 合法醫療器材資訊網
Translational research of one dynamic hip screw system ... | 合法醫療器材資訊網
華骨 | 合法醫療器材資訊網
Translational research of one dynamic hip screw system | 合法醫療器材資訊網
華骨 | 合法醫療器材資訊網
【華骨-髖骨板系統】許可證字號:衛署醫器製字第003728號
器材品名:華骨-髖骨板系統許可證字號:衛署醫器製字第003728號註銷狀態:註銷日期:註銷理由:有效日期:2022/07/10發證日期:2012...