Omnia Medical
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 11
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2557-2025 | Class II | TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree | July 15, 2024 |
| Z-2556-2025 | Class II | TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degr | July 15, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K242431 | Omnia Medical PsiF DNA System | June 6, 2025 |
| K240623 | Omnia Medical TiBrid-SA System | April 24, 2024 |
| K230424 | Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral Lumbar Plate | April 12, 2023 |
| K223321 | Omnia Medical Coupler-C Anterior Cervical Plate | March 13, 2023 |
| K212612 | Omnia Medical TiBrid-SC | November 15, 2022 |
| K203207 | Omnia Medical TiBrid-SA | December 23, 2020 |
| K192096 | Omnia Medical Trauma Screws | February 27, 2020 |
| K190363 | Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cag | February 21, 2020 |
| K191778 | Omnia Medical VBR | August 28, 2019 |
| K183659 | Omnia Medical Rotary PLIF System | February 6, 2019 |
| K172323 | Omnia Medical VBR | October 26, 2017 |