Expanding Orthopedics’ FDA Clearance for FLXfit15 3D-Articulated Expandable Cage

By Julie A. Vetalice

Expanding Orthopedics received FDA 510(k) clearance for the FLXfit™15 interbody cage that expands up to 4mm and enables controlled lordosis correction of up to 15⁰.

The system received CE Mark approval and launched in the EU in 2Q17. The higher range expansion of FLXfit15 is intended to support restoration of the lordosis angle up to 15⁰, while availability in a 32mm length can address smaller anatomies.

Source: Expanding Orthopedics Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory