Morgantown, WV, US · 8 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | 2 | 2024-04-24 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | 2 | 2023-04-12 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | 1 | 2025-06-06 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | 1 | 2022-11-15 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | 1 | 2020-02-27 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | 1 | 2020-02-21 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-07-15 | Class II | Ongoing | Z-2557-2025 | TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 … | — | Failure of fusion system instruments in the field. |
| 2024-07-15 | Class II | Ongoing | Z-2556-2025 | TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree. | — | Failure of fusion system instruments in the field. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-06-06 | K242431 | Omnia Medical PsiF DNA System | OUR | Class II | Orthopedic |
| 2024-04-24 | K240623 | Omnia Medical TiBrid-SA System | OVD | Class II | Orthopedic |
| 2023-04-12 | K230424 | Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral Lumbar Plate System | KWQ | Class II | Orthopedic |
| 2023-03-13 | K223321 | Omnia Medical Coupler-C Anterior Cervical Plate | KWQ | Class II | Orthopedic |
| 2022-11-15 | K212612 | Omnia Medical TiBrid-SC | OVE | Class II | Orthopedic |
| 2020-12-23 | K203207 | Omnia Medical TiBrid-SA | OVD | Class II | Orthopedic |
| 2020-02-27 | K192096 | Omnia Medical Trauma Screws | HWC | Class II | Orthopedic |
| 2020-02-21 | K190363 | Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage | MAX | Class II | Orthopedic |