Globus Medical, Inc. - FDA 510(k) Cleared Devices

Globus Medical, Inc. is a publicly traded orthopedic medical device company headquartered in Audubon, Pennsylvania. The company designs, develops, and commercializes products enabling surgeons to promote healing in patients with musculoskeletal disorders.

Globus Medical has received 169 FDA 510(k) clearances from 172 total submissions since its first clearance in 2003. The company's regulatory portfolio is dominated by orthopedic devices, representing 98% of all submissions. The latest FDA 510(k) clearance was granted in 2026, demonstrating continued innovation and market presence.

The company's cleared device portfolio includes spinal fixation systems, cervical spacers, acetabular systems, knee implants, and robotic-assisted surgical instruments. These products reflect Globus Medical's focus on spine, orthopedic trauma, and joint reconstruction technologies.

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

510(k) submissions have been managed by Nu Vasive, Incorporated as regulatory consultant.