FDA Product Code OSN: Software For Diagnosis/treatment
Software Associated With An Orthopedic Trauma Device Which Is Intended For The Diagnosis Or Treatment Of Traumatic Or Reconstructive Orthopedic Conditions
Leading manufacturers include Smith & Nephew, Inc. and Disior, Ltd..
FDA 510(k) Cleared Software For Diagnosis/treatment Devices (Product Code OSN)
About Product Code OSN - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code OSN since 2014, with 4 receiving FDA clearance (average review time: 125 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under OSN have taken an average of 93 days to reach a decision - down from 135 days historically, suggesting improved FDA processing for this classification.
OSN devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →