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Sign in to claim this brandSpineway SA
US
Last updated May 23, 2026
What Spineway SA makes
Spineway SA manufactures internal spinal fixation systems, including bone-screw assemblies, non-bioabsorbable spinal plates, and polymeric spinal fusion cages, both sterile and non-sterile. Their portfolio also includes reusable orthopaedic surgical procedure kits and spinal bone screws for surgical interventions. The company produces systems for anterior and posterior spinal stabilization, such as the Mont Blanc Evo, TWIN PEAKS, and Blue Mountain Cervical Plate System.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Spineway SA 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 Spineway SA manufacture?
Spineway SA specializes in spinal fixation devices, including bone-screw internal fixation systems (both sterile and non-sterile), non-bioabsorbable spinal plates, and polymeric spinal fusion cages. Their portfolio also covers reusable orthopaedic surgical procedure kits and spinal bone screws. These devices are designed for anterior and posterior spinal stabilization, such as their Mont Blanc Evo Systems, TWIN PEAKS, and Blue Mountain Cervical Plate System.
Where is Spineway SA based?
Spineway SA is headquartered in the United States. The company’s location is relevant for regulatory compliance, manufacturing oversight, and distribution of its spinal fixation devices.
Which regulatory registries or databases list Spineway SA’s devices?
Spineway SA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, regulators, and patients by providing standardized identification for each device.
How are Spineway SA’s devices classified under FDA regulations?
Spineway SA’s devices fall under FDA’s Class I and Class II categories. Class I generally includes low-risk devices like reusable surgical instruments, while Class II covers moderate-risk devices such as spinal fixation systems requiring special controls to ensure safety and effectiveness. Classification determines regulatory oversight and submission requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (923)
Page 17 of 19| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Blue Mountain Cervical Plate System | 1 | FDA UDI | Class II | Unknown |
| Mont Blanc Spinal Systems | 1 | FDA UDI | Class II | Active |
| Mont Blanc Spinal Systems | 2 | FDA UDI | Class II | Active |
| Mont Blanc Spinal Systems | 1 | FDA UDI | Class II | Active |
| Mont Blanc Spinal Systems | 1 | FDA UDI | Class II | Active |
| Mont Blanc MIS Spinal Systems | 1 | FDA UDI | Class II | Active |
| Mont Blanc Evo Systems | 1 | FDA UDI | Class II | Active |
| Mont Blanc Evo Systems | 1 | FDA UDI | Class II | Active |
| Mont Blanc MIS Spinal Systems | 1 | FDA UDI | Class II | Active |
| Mont Blanc Spinal Systems | 2 | FDA UDI | Class II | Active |
| Blue Mountain | 1 | FDA UDI | Class I | Active |
| Twin Peaks | 1 | FDA UDI | Class II | Active |
| Mont Blanc MIS Spinal Systems | 1 | FDA UDI | Class II | Active |
| Blue Mountain | 1 | FDA UDI | Class I | Active |
| Ayers Rock Cervical interbody fusion system | 1 | FDA UDI | Class II | Unknown |
| Mont Blanc | 1 | FDA UDI | Class I | Active |
| Ayers Rock Cervical interbody fusion system | 2 | FDA UDI | Class II | Unknown |
| Mont Blanc Evo Systems | 1 | FDA UDI | Class II | Active |
| Mont Blanc Spinal Systems | 1 | FDA UDI | Class II | Active |
| Blue Mountain Cervical Plate System | 2 | FDA UDI | Class II | Active |
| Mont Blanc MIS Spinal Systems | 1 | FDA UDI | Class I | Active |
| Mont Blanc MIS Spinal Systems | 1 | FDA UDI | Class II | Active |
| Mont Blanc MIS Spinal Systems | 1 | FDA UDI | Class II | Active |
| Mont Blanc Spinal Systems | 1 | FDA UDI | Class I | Active |
| Mont Blanc | 2 | FDA UDI | Class I | Active |
| Twin Peaks | 1 | FDA UDI | Class I | Active |
| Twin Peaks | 1 | FDA UDI | Class II | Active |
| Mont Blanc | 1 | FDA UDI | Class I | Active |
| Blue Mountain | 2 | FDA UDI | Class I | Active |
| Ayers Rock Cervical interbody fusion system | 1 | FDA UDI | Class II | Unknown |
| Blue Mountain | 1 | FDA UDI | Class I | Active |
| Mont Blanc Spinal Systems | 2 | FDA UDI | Class II | Active |
| Twin Peaks | 1 | FDA UDI | Class II | Unknown |
| Mont Blanc Spinal Systems | 1 | FDA UDI | Class I | Active |
| Mont Blanc Evo Systems | 1 | FDA UDI | Class II | Active |
| Twin Peaks | 1 | FDA UDI | Class II | Active |
| Mont Blanc Spinal Systems | 1 | FDA UDI | Class II | Active |
| Mont Blanc Evo Systems | 1 | FDA UDI | Class II | Active |
| Twin Peaks | 1 | FDA UDI | Class II | Unknown |
| Mont Blanc Evo Systems | 1 | FDA UDI | Class II | Active |
| Mont Blanc Evo Systems | 1 | FDA UDI | Class II | Active |
| Blue Mountain | 1 | FDA UDI | Class I | Active |
| Mont Blanc MIS Spinal Systems | 1 | FDA UDI | Class II | Active |
| Mont Blanc MIS Spinal Systems | 1 | FDA UDI | Class II | Active |
| Mont Blanc MIS Spinal Systems | 1 | FDA UDI | Class I | Active |
| Blue Mountain | 1 | FDA UDI | Class I | Active |
| Blue Mountain Cervical Plate System | 2 | FDA UDI | Class II | Active |
| Twin Peaks | 1 | FDA UDI | Class II | Active |
| Mont Blanc Spinal Systems | 1 | FDA UDI | Class II | Active |
| Blue Mountain | 2 | FDA UDI | Class I | Active |
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