FDA Registration
Active
🇺🇸 United States
Omnia Medical
Reg #: 3010560653
·
FEI: 3010560653
·
Expires 2026
Products
19
Proprietary Names
18
Establishment Types
2
Classifications
19
Registration Details
- Registration Name
- Omnia Medical
- Registration Number
- 3010560653
- FEI Number
- 3010560653
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6 Canyon Rd
- City
- MORGANTOWN
- State
- WV
- ZIP
- 26508
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112429
Owner / Operator
- Firm Name
- Omnia Medical
- Operator Number
- 10045103
- Address
- 6 Canyon Road, Suite 300
- City
- Morgantown
- State
- WV
- Postal Code
- 26508
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2023-06-07 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2020-12-29 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2025-08-20 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2019-12-16 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2020-02-25 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2013-10-21 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-03-05 |
| Crimper, Pin | HXQ | Class 1 | Orthopedic | No | 2015-01-06 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2015-01-06 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2015-01-06 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-10-21 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2023-02-27 |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | Class 2 | Orthopedic | No | 2023-02-27 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2022-01-18 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2022-01-18 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2024-01-29 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2020-01-16 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2023-01-17 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2020-12-29 |
Proprietary Names
Omnia Medical Trays
Giza
PsiF DNA
Omnia Medical VBR
Boxcar
Pedicle Screw Removal Tool
PSIF
Orthocision
Golden Spike
Not Available
DBLogix
Omnia Medical TiBrid
TiBrid-SC
Disc Prep
Omnia Medical TiBrid-SA
TiBrid-SA
sphynx
Omnia Medical Rotary PLIF System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility