Nuvasive, Inc. - FDA 510(k) Cleared Devices

Nuvasive, Inc. is a medical device company headquartered in San Diego, California. The company develops and markets surgical solutions focused on spine and orthopedic procedures. NuVasive operates globally and serves healthcare professionals and patients worldwide.

The company maintains a strong FDA 510(k) regulatory record with 90 FDA 510(k) clearances from 91 total submissions since 1999. Orthopedic devices represent the dominant category, accounting for the majority of the company's cleared submissions. The most recent clearance was granted in 2024, demonstrating continued regulatory activity and product innovation.

NuVasive's cleared device portfolio includes interbody systems, expandable vertebral body replacement systems, spinous process plate systems, and specialized orthopedic implants. These products support minimally invasive and open surgical approaches for spinal fusion and reconstruction procedures. The company also provides intraoperative neuromonitoring services through its NCS Neuromonitoring division.

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

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