FDA Product Code ONN: Intraoperative Orthopedic Joint Assessment Aid
Measurement And Interpretation Of Orthopedic Joint Information.
Leading manufacturers include Eventum Orthopaedics, Ltd. and Orthalign, Inc..
FDA 510(k) Cleared Intraoperative Orthopedic Joint Assessment Aid Devices (Product Code ONN)
About Product Code ONN - Regulatory Context
510(k) Submission Activity
16 total 510(k) submissions under product code ONN since 2007, with 16 receiving FDA clearance (average review time: 179 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under ONN have taken an average of 69 days to reach a decision - down from 204 days historically, suggesting improved FDA processing for this classification.
ONN devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →