AXIS SPINE TECHNOLOGIES LTD

Axis Spine Technologies Ltd specialises in spinal and orthopaedic devices. Its primary products include metallic spinal interbody fusion cages designed for anterior lumbar interbody fusion (ALIF) procedures. The company also manufactures reusable orthopaedic tools such as implant inserters/extractors, surgical distractors, bone awls, and sterilisation/disinfection containers. Additionally, it produces accessories like bone graft funnels and non-torque-limiting surgical instrument handles. Trial implants for spinal procedures are also part of its portfolio.

Axis Spine Technologies Ltd 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.

Axis Spine Technologies Ltd’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries track Class II devices authorised via the 510(k) pathway, ensuring compliance with FDA requirements for spinal and orthopaedic implants.

Axis Spine Technologies Ltd’s devices are classified as Class II under FDA regulations. This classification applies to spinal implants and orthopaedic tools that pose moderate risk but require general controls and special controls to ensure safety and effectiveness. Class II devices are authorised through the 510(k) premarket notification process or the UDI system, depending on the specific product.

The metallic spinal interbody fusion cages produced by Axis Spine Technologies Ltd are designed for anterior lumbar interbody fusion (ALIF) procedures. These cages are implanted between vertebrae in the lumbar spine to stabilise the spine, promote bone fusion, and alleviate pain caused by degenerative disc disease or spinal instability. They act as a scaffold to encourage bone growth and restore structural integrity.