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...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2019-02-01
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| Series: | Orthopaedic Surgery |
| Subjects: | |
| Online Access: | https://doi.org/10.1111/os.12415 |