Omnia Medical, LLC - FDA 510(k) Cleared Devices
Recent clearances: Omnia Medical PsiF DNA™ System, Omnia Medical TiBrid™-SA System, Omnia Medical Coupler-A™ Anterior Lumbar Plate System
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Omnia Medical, LLC Orthopedic ✕
11 devices
Cleared
Jun 06, 2025
Omnia Medical PsiF DNA™ System
Orthopedic
294d
Cleared
Apr 24, 2024
Omnia Medical TiBrid™-SA System
Orthopedic
50d
Cleared
Apr 12, 2023
Omnia Medical Coupler-A™ Anterior Lumbar Plate System
Orthopedic
54d
Cleared
Mar 13, 2023
Omnia Medical Coupler-C Anterior Cervical Plate
Orthopedic
133d
Cleared
Nov 15, 2022
Omnia Medical TiBrid-SC
Orthopedic
455d
Cleared
Dec 23, 2020
Omnia Medical TiBrid-SA
Orthopedic
54d
Cleared
Feb 27, 2020
Omnia Medical Trauma Screws
Orthopedic
206d
Cleared
Feb 21, 2020
Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia...
Orthopedic
371d
Cleared
Aug 28, 2019
Omnia Medical VBR
Orthopedic
57d
Cleared
Feb 06, 2019
Omnia Medical Rotary PLIF System
Orthopedic
41d
Cleared
Oct 26, 2017
Omnia Medical VBR
Orthopedic
86d