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US
Last updated May 24, 2026
What NEUROSTRUCTURES, INC makes
NeuroStructures, Inc. manufactures orthopaedic and spinal fixation devices, including non-bioabsorbable spinal plates, polymeric interbody fusion cages, and internal fixation systems with screws and plates. Their portfolio also includes reusable positioning instruments for orthopaedic prosthesis implantation and non-sterile bone-screw fixation systems for spinal stabilization.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. NeuroStructures, Inc. 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 NeuroStructures, Inc. manufacture?
NeuroStructures, Inc. specializes in orthopaedic and spinal fixation devices. Their product portfolio includes general internal orthopaedic fixation system implantation kits, spinal fixation plates made from non-bioabsorbable materials, polymeric spinal interbody fusion cages, and bone-screw internal spinal fixation systems that are non-sterile. They also produce reusable positioning instruments for orthopaedic prosthesis implantation, designed to assist surgeons during surgical procedures.
Where is NeuroStructures, Inc. based?
NeuroStructures, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under U.S. medical device regulations.
Which regulatory registries list NeuroStructures, Inc.’s devices?
NeuroStructures, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the U.S. market, ensuring traceability and compliance with regulatory requirements.
How are NeuroStructures, Inc.’s devices classified under U.S. regulations?
NeuroStructures, Inc.’s devices fall under Class II classification according to FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as spinal fixation systems and orthopaedic implants.
What distinguishes NeuroStructures, Inc.’s spinal fixation devices from others in the market?
NeuroStructures, Inc. focuses on non-bioabsorbable spinal fixation plates, polymeric interbody fusion cages, and non-sterile bone-screw systems, which are designed for spinal stabilization. Their devices often include reusable positioning instruments for precision during orthopaedic surgeries, catering to both spinal and general orthopaedic fixation needs with a focus on durability and surgical efficiency.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- neurostructures.com
- —
- —
- [email protected]
- Phone
- 8003526103
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 079391677
Catalogue (718)
Page 15 of 15| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Arco™-SA Lumbar Cage System | K173082 | FDA 510(k) | Class II | Active |
| Belvedere™ Lateral Plating System | K153097 | FDA 510(k) | Class II | Active |
| Cortina™ [MAX] Lumbar Cage System | K192248 | FDA 510(k) | Class II | Active |
| Tempus Cervical Plate System | K120515 | FDA 510(k) | Class II | Active |
| Transom Anterior Cervical Plate | K142060 | FDA 510(k) | Class II | Active |
| Trifore(tm) Cervical Plating System | K171112 | FDA 510(k) | Class II | Active |
| Tempus(tm) Cervical Plate System | K131374 | FDA 510(k) | Class II | Active |
| Resolute Facet Screw System | K121551 | FDA 510(k) | U | Active |
| Cavetto-SA Cervical Cage System | K200115 | FDA 510(k) | Class II | Active |
| Cavetto [MAX] Cervical Cage System | K201769 | FDA 510(k) | Class II | Active |
| Palladian Lumbar Pedicle Screw System | K143230 | FDA 510(k) | Class II | Active |
| Transept Cervical Plate System | K200927 | FDA 510(k) | Class II | Active |
| Cavetto-SA Cervical Cage System | K173077 | FDA 510(k) | Class II | Active |
| Neurostructures Cavetto® [MAX] Cervical Cage System | K181590 | FDA 510(k) | Class II | Active |
| Neurostructures Cavetto® Cervical Cage System | K172320 | FDA 510(k) | Class II | Active |
| Oculus-SA Lumbar Cage System | K202190 | FDA 510(k) | Class II | Active |
| Cortina [MAX] Lumbar Cage System | K180431 | FDA 510(k) | Class II | Active |
| Cortina™ Lumbar Cage System | K171914 | FDA 510(k) | Class II | Active |
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