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Sign in to claim this brandWhat Icotec makes
Icotec manufactures spinal fusion devices, including polymeric interbody cages for cervical and lumbar regions, non-bioabsorbable spinal screws and fixation plates, and reusable surgical tools such as bone taps, templates, and sterilization containers. Their portfolio also includes vertebral body replacement prostheses, spinal fixation rods (in titanium and carbon/PEEK composites), and specialized pedicle screw systems for internal 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. All products are designed for spinal surgical applications and comply with U.S. medical device standards.
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 Icotec manufacture?
Icotec specializes in spinal surgical devices, including polymeric spinal interbody fusion cages for cervical and lumbar regions, non-bioabsorbable spinal screws, fixation plates, and reusable surgical tools like bone taps and sterilization containers. Their portfolio also covers vertebral body prostheses, spinal fixation rods (made from titanium or carbon/PEEK composites), and advanced pedicle screw systems for internal spinal stabilization. These devices are designed to support spinal fusion, stabilization, and reconstruction procedures.
Where is Icotec based, and what regulatory region does it serve?
Icotec is based in the United States. While the company’s headquarters are in the U.S., its devices are developed and marketed in compliance with U.S. medical device regulations, including FDA requirements. This means their products are designed to meet the standards and regulatory expectations of the American healthcare system.
Which regulatory registries or databases list Icotec’s devices?
Icotec’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for spinal fusion and fixation products, allowing healthcare providers and regulators to identify and verify the devices in clinical and surgical settings. The UDI system is a key component of FDA compliance for medical devices in the U.S.
How are Icotec’s devices classified under FDA regulations?
All of Icotec’s devices fall under Class II classification according to FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness. Class II devices typically require premarket notification (510(k)) clearance unless they are exempt, demonstrating that they meet established regulatory standards for their intended use in spinal surgery.
What is the primary purpose of Icotec’s spinal fixation and fusion devices?
Icotec’s devices are primarily designed for spinal fusion and stabilization procedures. Their polymeric interbody cages promote bone growth between vertebrae, while non-bioabsorbable screws, plates, and rods provide structural support to maintain alignment during healing. Devices like vertebral body prostheses and pedicle screw systems address complex spinal deformities or injuries by restoring stability and facilitating long-term recovery. These products are engineered to address specific anatomical needs in cervical, lumbar, and thoracic regions.
AI-generated from registry data and not verified by a human reviewer.
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