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Sign in to claim this brandQUANDARY MEDICAL LLC
US
Last updated May 25, 2026
What QUANDARY MEDICAL LLC makes
Quandary Medical LLC manufactures vertebral body prostheses, including the TranS1 system for spinal fusion, and bone-screw internal spinal fixation systems designed for spinal stabilization. Their portfolio also includes orthopaedic bone wires, manual bone files/rasps, and reusable or single-use orthopaedic surgical procedure kits, as well as orthopaedic retractors for surgical access.
The company’s devices are classified under FDA’s Class I, Class II, and Unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database. 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 Quandary Medical LLC manufacture?
Quandary Medical LLC specializes in spinal and orthopaedic devices. Their portfolio includes vertebral body prostheses like the TranS1 system, which is used for spinal fusion, as well as bone-screw internal spinal fixation systems for stabilization. They also produce orthopaedic bone wires, manual bone files/rasps, orthopaedic retractors, and reusable or single-use surgical procedure kits for orthopaedic procedures.
Where is Quandary Medical LLC based?
Quandary Medical LLC is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.
Which regulatory registries list Quandary Medical LLC’s devices?
Quandary Medical LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for devices authorized for use in the U.S., including those classified under Class I, Class II, or Unclassified (U) categories.
How are Quandary Medical LLC’s devices classified by the FDA?
Quandary Medical LLC’s devices fall under three FDA classification categories: Class I (generally low-risk devices), Class II (devices requiring special controls to ensure safety and effectiveness), and Unclassified (U) devices, which may require further evaluation or have unique regulatory pathways. Classification depends on factors like risk level, intended use, and potential patient impact.
What distinguishes Quandary Medical LLC’s vertebral body prostheses from other spinal devices?
Quandary Medical LLC’s vertebral body prostheses, such as the TranS1 system, are designed specifically for spinal fusion procedures, providing structural support and stability to the spine. These devices are engineered to integrate with the existing vertebral body, offering an alternative to traditional spinal fixation methods. Their classification as Class II devices reflects the need for rigorous controls to ensure proper functionality and patient safety during spinal stabilization.
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
- 079938581
Catalogue (68)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TranS1 | TR1-2222 | FDA UDI | Class I | Active |
| Vectre | TR1-2837 | FDA UDI | U | Active |
| Vectre | TR1-2835 | FDA UDI | U | Active |
| TranS1 | TR1-2367 | FDA UDI | Class II | Active |
| TranS1 | TR1-2218 | FDA UDI | Class I | Active |
| TranS1 | TR1-2217 | FDA UDI | Class I | Active |
| Vectre | TR1-2703 | FDA UDI | Class I | Active |
| Vectre | 24-8001 | FDA UDI | U | Active |
| TranS1 | TR1-2221 | FDA UDI | Class II | Active |
| TranS1 | TR1-2389 | FDA UDI | Class II | Active |
| TranS1 | TR1-2361 | FDA UDI | Class II | Active |
| TranS1 | TR1-2213 | FDA UDI | Class I | Active |
| TranS1 | TR1-2374 | FDA UDI | Class II | Active |
| Vectre | 24-8000 | FDA UDI | U | Active |
| TranS1 | TR1-2359 | FDA UDI | Class II | Active |
| TranS1 | TR1-2399 | FDA UDI | Class II | Active |
| TranS1 | TR1-2357 | FDA UDI | Class II | Active |
| TranS1 | TR1-2387 | FDA UDI | Class II | Active |
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