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Last updated May 23, 2026
What X-Bolt Orthopaedics makes
X-Bolt Orthopaedics manufactures the X-BOLT Hip Fracture Fixation System, which is a medical device designed for the stabilization and fixation of hip fractures.
The company is based in the US, and its product portfolio is regulated as a Class II device listed under the FDA 510(k) regulatory pathway.
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 X-Bolt Orthopaedics manufacture?
X-Bolt Orthopaedics specializes in orthopaedic medical devices. Specifically, the company develops the X-BOLT Hip Fracture Fixation System, which is designed to stabilize and secure hip fractures during surgical treatment. This device falls under the category of orthopaedic fixation hardware.
Where is X-Bolt Orthopaedics based?
X-Bolt Orthopaedics is headquartered in the United States. The company’s operations and regulatory compliance are aligned with US-based medical device standards.
Which regulatory registries or databases list X-Bolt Orthopaedics’ devices?
X-Bolt Orthopaedics’ devices are listed under the FDA’s 510(k) regulatory pathway. This pathway is used for Class II medical devices, which require pre-market notification to demonstrate substantial equivalence to a legally marketed predicate device.
How are X-Bolt Orthopaedics’ devices classified under medical device regulations?
X-Bolt Orthopaedics’ devices, such as the X-BOLT Hip Fracture Fixation System, are classified as Class II medical devices. This classification is determined by the FDA based on the level of risk associated with the device, requiring compliance with special controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (62)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pro-X1 | XNI-028 | FDA UDI | Class II | Active |
| Pro-X1 | XBT110375R | FDA UDI | Class II | Active |
| Pro-X1 | XBT105125 | FDA UDI | Class II | Active |
| Pro-X1 | XBT110300L | FDA UDI | Class II | Active |
| Pro-X1 | XBT110400L | FDA UDI | Class II | Active |
| Pro-X1 | XBT050050 | FDA UDI | Class II | Active |
| Pro-X1 | XBT110350L | FDA UDI | Class II | Active |
| Pro-X1 | XBT105085 | FDA UDI | Class II | Active |
| Pro-X1 | XBT050035 | FDA UDI | Class II | Active |
| Pro-X1 | XNI-100-X | FDA UDI | Class II | Active |
| Pro-X1™ Trochanteric Nailing System | K221621 | FDA 510(k) | Class II | Active |
| X-BOLT Hip Fracture Fixation System | K181640 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- X-Bolt Orthopedics Santry Dublin · IE FEI 3010368646