Dio Medical Corporation - FDA 510(k) Cleared Devices
Recent clearances: Rexious Spinal Fixation System, FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, UNITY Sacroiliac Joint Fixation System
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dio Medical Corporation Orthopedic ✕
4 devices
Cleared
Oct 25, 2022
Rexious Spinal Fixation System
Orthopedic
76d
Cleared
Oct 18, 2022
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate...
Orthopedic
54d
Cleared
Oct 13, 2022
UNITY Sacroiliac Joint Fixation System
Orthopedic
59d
Cleared
Oct 05, 2022
FaSet Fixation System
Orthopedic
47d