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

Box Spine, LLC designs and manufactures pre-sterilized spinal implants and surgical instruments for ambulatory surgery centers. The company specializes in single-use, ready-to-use surgical kits that simplify spinal fusion procedures in the ASC setting. Box Spine operates with a manufacturing facility in Tulsa, Oklahoma.

The company has received 1 FDA 510(k) clearance from 1 total submission. Box Spine focuses exclusively on Orthopedic devices, with its flagship product being the Duet™ Spinal Fixation System. The company achieved its first clearance in 2026 and remains actively engaged in the market.

Box Spine's portfolio addresses both lumbar and cervical fusion applications. The company emphasizes operational efficiency, infection reduction, and cost containment through simplified, integrated surgical ecosystems designed specifically for the ASC environment rather than traditional hospital-based models.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the FDA 510(k) database.

510(k) submissions have been managed by Applied Technical Services (Empirical Technologies) as regulatory consultant.