Omnia Medical, LLC - FDA 510(k) Cleared Devices

Omnia Medical, LLC is an orthopedic implant company based in Morgantown, West Virginia. The company develops innovative surgical implants and instrumentation focused on spinal fusion and joint stabilization procedures. Omnia Medical's product portfolio emphasizes reproducible surgical techniques and improved patient outcomes.

The company has received 11 FDA 510(k) clearances from 11 total submissions since its first clearance in 2017. All submissions have focused on orthopedic devices. The most recent clearance was in 2025, demonstrating continued regulatory activity and product innovation.

Omnia Medical's cleared devices span multiple spinal and joint applications, including sacroiliac joint stabilization systems, interbody fusion devices for cervical and lumbar spine procedures, vertebral body replacement implants, and trauma fixation solutions. The company's instrumentation and implant designs target both minimally invasive and open surgical approaches.

For detailed information on specific device names, product codes, and individual clearance dates, consult the FDA 510(k) database or contact the company directly.

Regulatory submissions have been managed by Jalex Medical, Jalex Medical, LLC and Sagemar Medical, LLC.