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

Alphatec Spine, Inc. is a spine surgery medical device company based in Carlsbad, California. The company develops and markets surgical solutions for spinal fusion and fixation procedures.

Alphatec Spine maintains a strong FDA 510(k) regulatory record with 93 FDA 510(k) clearances from 93 total submissions. The company specializes in Orthopedic devices, which represent 91% of its submission portfolio. Clearances span from 2005 to 2026, demonstrating sustained regulatory activity and recent market engagement.

Recent cleared devices include robotic navigation systems, interbody spacer systems, anterior cervical plate systems, and spinal fixation platforms. The company's product portfolio addresses multiple surgical approaches including anterior cervical discectomy and fusion, transforaminal lumbar interbody fusion, and posterior fixation techniques.

Explore the complete regulatory history, device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Alphatec Spine, Inc. as regulatory consultant. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.