Orthoxel is one of 55 FDA 510(k) medical device manufacturers from Ireland in the dataset, ranked by real submission volume.
Orthoxel - FDA 510(k) Cleared Devices
Recent clearances: Apex Femoral Nailing System
2
Total
2
Cleared
0
Denied
Orthoxel has 2 FDA 510(k) cleared medical devices. Based in Bishopstown, IE.
Historical record: 2 cleared submissions from 2017 to 2018. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Orthoxel Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Musculoskeletal Clinical Regulatory Advisers, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Orthoxel
2 devices