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

Vy Spine, LLC develops and manufactures orthopedic spinal implants and surgical solutions. The company offers a comprehensive product portfolio spanning cervical, thoracic, lumbar, and sacroiliac spine applications. With a manufacturing facility in Tallahassee, US, Vy Spine combines core spine technologies with innovative materials and designs to address simple to complex surgical needs.

The company has received 21 FDA 510(k) clearances from 21 total submissions since its first clearance in 2021. All submissions have focused on orthopedic devices. The latest clearance in 2026 reflects continued regulatory activity and product development within the spinal implant market.

Vy Spine's cleared device portfolio includes anterior cervical plate systems, facet screw systems, vertebral body replacement systems, interbody fusion devices, laminoplasty systems, and percutaneous screw fixation systems. The company emphasizes proprietary technologies including OsteoVy™ 3D-printed lattice structures for osseointegration and NanoVy™ advanced nano coatings for implant performance.

Explore the complete list of Vy Spine, LLC FDA 510(k) cleared devices, including device names, product codes, and clearance dates in the database.

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