FDA Product Code MVA: Orthosis, Cranial
Leading manufacturers include Invent Medical USA, LLC, Otto Bock Healthcare LP and Orthomerica Products, Inc..
FDA 510(k) Cleared Orthosis, Cranial Devices (Product Code MVA)
About Product Code MVA - Regulatory Context
510(k) Submission Activity
43 total 510(k) submissions under product code MVA since 1998, with 42 receiving FDA clearance (average review time: 177 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under MVA have taken an average of 58 days to reach a decision - down from 180 days historically, suggesting improved FDA processing for this classification.
MVA devices are reviewed by the Neurology panel. Browse all Neurology devices →