RED ONE MEDICAL DEVICES LLC

RED ONE MEDICAL DEVICES LLC specializes in the design, manufacturing, and supply of advanced surgical implants and medical appliances, with a primary focus on spinal fusion devices, prosthetic implants, and orthopedic surgical solutions. The company leverages precision manufacturing techniques to produce FDA-regulated Class II and III implantable devices, including spinal instrumentation, interbody fusion cages, and custom prosthetic components tailored for clinical use. Their technical expertise spans biomaterials selection, sterile packaging validation, ISO 13485-compliant production processes, and regulatory documentation for 510(k) submissions. A key differentiator is their deep specialization in spinal implant systems, consistently delivering mission-critical devices to VA and DoD medical facilities under tight clinical timelines. The contractor maintains a strong, recurring relationship with the Department of Veterans Affairs and the Department of Defense, supplying implantable surgical devices directly to VA healthcare networks and military medical centers. Their work supports veteran care pathways involving spinal reconstruction, trauma recovery, and mobility restoration, often fulfilling urgent clinical needs through non-competitive or limited-source procurement mechanisms. Their industry focus centers on NAICS 339113 (Surgical Appliance and Supplies Manufacturing), with secondary activity in surgical instrument manufacturing and medical device wholesaling. This positions them as a niche supplier within the orthopedic and spinal implant market, serving government healthcare systems that require reliable, high-integrity implantable devices with full traceability and regulatory compliance. As a Service-Disabled Veteran-Owned Business headquartered in Savannah, Georgia, RED ONE MEDICAL DEVICES LLC operates under a small business structure (2L) and leverages its SDVOSB certification to support federal procurement goals. The company’s geographic presence and specialized manufacturing capabilities make it a trusted, mission-aligned partner for federal medical supply chains requiring precision-engineered, clinically validated surgical solutions.