FDA Registration
Active
🇺🇸 United States
ROMD, LLC
Reg #: 3008959459
·
FEI: 3008959459
·
Expires 2026
Products
5
Proprietary Names
9
Establishment Types
2
Classifications
5
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Registration Details
- Registration Name
- ROMD, LLC
- Registration Number
- 3008959459
- FEI Number
- 3008959459
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2967 Waterview Drive
- City
- Rochester Hills
- State
- MI
- ZIP
- 48309
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110177
Owner / Operator
- Firm Name
- Royal Oak Medical Devices
- Operator Number
- 10036878
- Address
- 2967 Waterview Drive
- City
- Rochester Hills
- State
- MI
- Postal Code
- 48309
- Country
- US
- Correspondent
- David Zagorowski
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2012-10-26 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2015-12-23 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2011-12-30 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2011-12-30 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2011-12-30 |
Proprietary Names
Helena IBFD System
Hippeis IBFD System
Opus Medical Gemini IBFD System
Royal Oak IBFD System
Royal Oak Pedicle Screw System
VTI InterLink Pedicle Screw System
Athena Pedicle Screw System
Agoge Pedicle Screw System
Opus Medical Capella Pedicle Screw System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device