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Sign in to claim this brandWhat FX Shoulder Solutions, Inc. makes
FX Shoulder Solutions, Inc. produces reusable, non-medicated orthopaedic surgical procedure kits designed for shoulder-related interventions. These kits are intended for use in surgical settings where precise instrumentation is required for fracture fixation or joint reconstruction procedures.
The company’s products are classified as Class II medical devices under US regulations and are listed in the FDA’s 510(k) and UDI registries. 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 FX Shoulder Solutions, Inc. manufacture?
FX Shoulder Solutions, Inc. specializes in reusable, non-medicated orthopaedic surgical procedure kits. These kits are specifically designed for shoulder-related surgical procedures, such as fracture fixation or joint reconstruction, where precise instrumentation is essential.
Where is FX Shoulder Solutions, Inc. based?
FX Shoulder Solutions, Inc. is headquartered in the United States. The company’s location ensures compliance with US regulatory standards for medical devices.
Which regulatory registries list FX Shoulder Solutions, Inc.’s devices?
FX Shoulder Solutions, Inc.’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identification (UDI) system. These registries track devices that have undergone the necessary regulatory pathways for market authorization in the US.
How are FX Shoulder Solutions, Inc.’s devices classified under US regulations?
The company’s devices fall under Class II classification in the US regulatory framework. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as orthopaedic surgical kits for shoulder procedures.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 115052068
Catalogue (37)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Fx V135 | 950-1809 | FDA UDI | Class II | Active |
| Fx V135 | 950-5803 | FDA UDI | Class II | Active |
| Fx V135 | 950-6815 | FDA UDI | Class II | Active |
| Fx V135 | 950-6809 | FDA UDI | Class II | Active |
| Fx V135 | 950-3803 | FDA UDI | Class II | Active |
| Fx V135 | 950-1812 | FDA UDI | Class II | Active |
| Fx V135 | 950-4815 | FDA UDI | Class II | Active |
| Fx V135 | 950-3812 | FDA UDI | Class II | Active |
| Fx V135 | 950-1803 | FDA UDI | Class II | Active |
| Fx V135 | 950-1806 | FDA UDI | Class II | Active |
| Fx V135 | 950-5815 | FDA UDI | Class II | Active |
| Fx V135 | 950-2818 | FDA UDI | Class II | Active |
| Fx V135 | 950-6818 | FDA UDI | Class II | Active |
| Fx V135 | 950-5809 | FDA UDI | Class II | Active |
| Fx V135 | 950-2815 | FDA UDI | Class II | Active |
| Fx V135 | 950-4809 | FDA UDI | Class II | Active |
| Fx V135 | 950-4806 | FDA UDI | Class II | Active |
| Fx V135 | 950-3809 | FDA UDI | Class II | Active |
| Fx V135 | 950-4812 | FDA UDI | Class II | Active |
| Fx V135 | 950-6803 | FDA UDI | Class II | Active |
| Fx V135 | 950-3818 | FDA UDI | Class II | Active |
| Fx V135 | 950-1818 | FDA UDI | Class II | Active |
| Fx V135 | 950-3815 | FDA UDI | Class II | Active |
| Fx V135 | 950-2812 | FDA UDI | Class II | Active |
| Fx V135 | 950-4803 | FDA UDI | Class II | Active |
| Fx V135 | 950-1815 | FDA UDI | Class II | Active |
| Fx V135 | 950-5812 | FDA UDI | Class II | Active |
| Fx V135 | 950-6806 | FDA UDI | Class II | Active |
| Fx V135 | 950-2806 | FDA UDI | Class II | Active |
| Fx V135 | 950-2803 | FDA UDI | Class II | Active |
| Fx V135 | 950-5818 | FDA UDI | Class II | Active |
| Fx V135 | 950-6812 | FDA UDI | Class II | Active |
| Fx V135 | 950-5806 | FDA UDI | Class II | Active |
| Fx V135 | 950-2809 | FDA UDI | Class II | Active |
| Fx V135 | 950-4818 | FDA UDI | Class II | Active |
| Fx V135 | 950-3806 | FDA UDI | Class II | Active |
| FX V135 EASYTECH® Shoulder System | K254154 | FDA 510(k) | Class II | Active |
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