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Correlation Between Conditional Approval and Customized Bone Implant Devices
This report aims to summarize key concerns regarding customized devices and conditional approval during the premarket evaluation of bone implants, and to explore the correlation between them. Based on the experience of approval of the first domestic custom‐designed bone implant, we consider the proc...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons Australia, Ltd
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6430462/ https://www.ncbi.nlm.nih.gov/pubmed/30834707 http://dx.doi.org/10.1111/os.12415 |