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Summary of the FDA virtual public workshop on spinal device clinical review held on September 17, 2021
Article (Web of Science)
Overview
Research
Additional Document Info
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Overview
cited authors
Devlin, Vincent J.; Jean, Ronald; Peat, Capt Raquel; Jiang, Hongying; Anderson, Paul A.; Benson, John C.; Brodke, Darrel S.; Golish, S. Raymond; Kebaish, Khaled M.; Larson, A. Noelle; Serhan, Hassan
publication date
September 1, 2022
webpage
Web of Science
published in
SPINE JOURNAL
Journal
Research
category
ORTHOPEDICS
Category
keywords
Adverse events
Clinical outcome assessments
Clinical study endpoints
De Novo Classification request
Health disparities
Humanitarian device exemption
Investigational device exemption
Orthopedic devices
Premarket approval
Premarket notification
Secondary surgical procedures
Spinal devices
Spinal fusion
Study enrollment criteria
Additional Document Info
start page
1423
end page
1433
volume
22
issue
9