Spectrum Spine, Inc. - FDA 510(k) Cleared Devices

Spectrum Spine, Inc. develops spinal implant systems for orthopedic surgery. The company operates with a manufacturing facility in Jasper, US, and focuses on innovative solutions for spinal fusion procedures.

The company has received 3 FDA 510(k) clearances from 3 total submissions. All submissions fall within the Orthopedic device category. Spectrum Spine achieved its first clearance in 2024 and most recently in 2025, demonstrating active regulatory engagement.

Recent cleared devices include expandable titanium systems for posterior lumbar interbody fusion, as well as lumbar and cervical cage systems. These products reflect the company's specialization in spinal fusion technologies and implant solutions for complex spinal procedures.

For detailed information on device names, product codes, and specific clearance dates, review the company's complete 510(k) submission history.

Regulatory submissions have been managed by MRC Global, LLC and MRC Global.