Southern Spine LLC

Southern Spine LLC specializes in spinal fixation devices, including expandable interbody systems like the Deploy™ Expandable Interbody System, non-bioabsorbable spinal fixation plates, and interbody fusion cages made of metal or polymer. Their portfolio also covers reusable surgical instruments such as instrument trays, manual bone files/rasps, and orthopaedic implantation sleeves. Additionally, they produce spinal implant trials for testing purposes. These devices are designed for both cervical and lumbar spinal applications.

Southern Spine LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance, as it operates under the jurisdiction of the U.S. Food and Drug Administration (FDA).

Yes, Southern Spine LLC’s devices are recorded in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability in the healthcare system.

All of Southern Spine LLC’s devices fall under FDA Class II classification. This classification applies to devices that generally pose moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness. Class II devices are subject to performance standards or post-market surveillance requirements.

The reusable instrument trays, manual bone files/rasps, and orthopaedic implantation sleeves produced by Southern Spine LLC are designed to assist surgeons during spinal procedures. These tools are engineered for durability and precision, ensuring they can be sterilized and reused across multiple surgeries while maintaining their functionality for tasks like bone preparation and spinal stabilization.