Orthonovis, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Orthonovis, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Cannulated Screw and Kirschner (K wire) System, BPS Wrist Fracture System, BPS - Bone Fragment Fixation Plates, Screws and Washers
5
Total
5
Cleared
0
Denied
Orthonovis, Inc. has 5 FDA 510(k) cleared medical devices. Based in Palm Coast, US.
Latest FDA clearance: Oct 2025. Active since 2022. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Orthonovis, Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Simple Path, LLC and Empirical Technologies.
FDA 510(k) Regulatory Record - Orthonovis, Inc.
5 devices
Cleared
Oct 02, 2025
Cannulated Screw and Kirschner (K wire) System
Orthopedic
34d
Cleared
Mar 17, 2025
BPS Wrist Fracture System
Orthopedic
25d
Cleared
Feb 06, 2025
BPS - Bone Fragment Fixation Plates, Screws and Washers
Orthopedic
27d
Cleared
Oct 04, 2024
BPS Wrist Fracture System
Orthopedic
58d
Cleared
Aug 25, 2022
ONX Large External Fixation System
Orthopedic
254d