Centinel Spine, LLC - FDA 510(k) Cleared Devices

Centinel Spine, LLC is a specialized spine medical device company focused on total disc replacement technology. The company develops motion-preservation and disc arthroplasty solutions for cervical and lumbar spinal disease, with a manufacturing facility in West Chester, US.

Centinel Spine has received 3 FDA 510(k) clearances from 3 total submissions since its first clearance in 2022. The company specializes exclusively in Orthopedic devices, representing 100% of its regulatory submissions. The latest clearance was issued in 2025, confirming active regulatory engagement.

The company's product portfolio includes prodisc® L instruments for lumbar applications and prodisc® C instruments for cervical applications. These devices leverage proprietary technologies including the Match-the-Disc™ system and prodisc® CORE technology, designed to enable customized surgical solutions based on patient anatomy and surgeon preference.

Explore the complete list of cleared device names, product codes, and clearance dates in the 510(k) database.

510(k) submissions have been managed by Mcra, LLC as regulatory consultant.