Is this your brand? Sign in to claim ownership.
Sign in to claim this brandRoyal Oak Medical Devices
US
Last updated May 23, 2026
What Royal Oak Medical Devices makes
Royal Oak Medical Devices manufactures spinal fixation hardware, including non-bioabsorbable pedicle screws, internal fixation rods and connectors, polymeric interbody fusion cages, and external spinal stabilization systems. Their products are designed for internal spinal stabilization and fusion procedures, with applications in degenerative disc disease and spinal deformity correction.
The company’s portfolio is regulated under FDA Class II devices, with products listed via 510(k) premarket notifications and covered under the UDI system. All devices are tracked in the FDA’s regulatory databases, and the manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Royal Oak Medical Devices manufacture?
Royal Oak Medical Devices specializes in spinal fixation hardware. Their product line includes non-bioabsorbable spinal bone screws, internal spinal fixation systems like rods and connectors, polymeric spinal interbody fusion cages, and external spinal fixation systems. These devices are primarily used for internal spinal stabilization and fusion, addressing conditions such as degenerative disc disease and spinal deformities.
Where is Royal Oak Medical Devices based?
Royal Oak Medical Devices is headquartered in the United States. The company’s location influences its regulatory compliance, particularly under the FDA’s jurisdiction for Class II devices.
Which regulatory registries or databases list Royal Oak Medical Devices’ devices?
Royal Oak Medical Devices’ devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries track Class II spinal fixation products, ensuring compliance with U.S. medical device regulations.
How are Royal Oak Medical Devices’ products classified under FDA regulations?
Royal Oak Medical Devices’ products fall under FDA Class II classification. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as spinal fixation hardware. The company submits 510(k) notifications to demonstrate regulatory compliance.
Why are Royal Oak Medical Devices’ devices tracked under the FDA’s UDI system?
The FDA’s Unique Device Identifier (UDI) system ensures traceability and transparency in the medical device supply chain. Since Royal Oak Medical Devices’ products are Class II spinal fixation devices, they must comply with UDI requirements to facilitate tracking, reporting, and regulatory oversight throughout their lifecycle.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (73)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Royal Oak Pedicle Screw System | SR5.5-90 | FDA UDI | Class II | Active |
| Royal Oak Pedicle Screw System | PS5.5-7.5-40 | FDA UDI | Class II | Active |
| Royal Oak Pedicle Screw System | PS5.5-5.5-50 | FDA UDI | Class II | Active |
| Royal Oak Pedicle Screw System | CCF5.5-31 | FDA UDI | Class II | Active |
| Royal Oak Pedicle Screw System | PS5.5-5.5-35 | FDA UDI | Class II | Active |
| Royal Oak IBFD Implant System | TL251008-0001 | FDA UDI | Class II | Active |
| Royal Oak IBFD Implant System | 4502081 | FDA UDI | Class II | Active |
| Royal Oak Pedicle Screw System | CCF5.5-34 | FDA UDI | Class II | Active |
| Royal Oak IBFD Implant System | PP221008-0001 | FDA UDI | Class II | Active |
| Royal Oak IBFD Implant System | PP261010-0001 | FDA UDI | Class II | Active |
| Royal Oak Pedicle Screw System | PS5.5-7.5-55 | FDA UDI | Class II | Active |
| Royal Oak Pedicle Screw System | CCV5.5-40-45 | FDA UDI | Class II | Active |
| Royal Oak Pedicle Screw System | CR5.5-60 | FDA UDI | Class II | Active |
| Royal Oak Pedicle Screw System | PS5.5-4.5-35 | FDA UDI | Class II | Active |
| Royal Oak Pedicle Screw System | PS5.5-5.5-45 | FDA UDI | Class II | Active |
| Royal Oak Pedicle Screw System | CCF5.5-28 | FDA UDI | Class II | Active |
| Royal Oak Pedicle Screw System | PS5.5-4001 | FDA UDI | Class II | Active |
| Royal Oak Pedicle Screw System | PS5.5-7.5-45 | FDA UDI | Class II | Active |
| Royal Oak IBFD Implant System | PP221014-0001 | FDA UDI | Class II | Active |
| Royal Oak IBFD Implant System | PP261008-0001 | FDA UDI | Class II | Active |
| Royal Oak IBFD Implant System | TL251012-0001 | FDA UDI | Class II | Active |
| Athena Pedicle Screw System | K110046 | FDA 510(k) | Class II | Active |
| Helena System | K110177 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.