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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...

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Detalles Bibliográficos
Autores principales: Guo, Xiao‐lei, Liu, Bin, Lu, Zhong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons Australia, Ltd 2019
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