Spineology Rampart One Standard ALIF Interbody Gains Standalone FDA Clearance

By Julie A. Vetalice

Spineology received FDA 510(k) clearance to market the Rampart One™ Standard ALIF device without supplemental fixation.

Previously cleared for use with fixation in 2Q17, this additional standalone clearance will more fully support full market release of the device which has successfully completed beta launch.

Rampart One ALIF includes standard and oblique interbody devices with integrated fixation screws, and are manufactured from Invibio® PEEK-OPTIMA® HA Enhanced material to support bone ongrowth.

Sources: Spineology Inc.; ORTHOWORLD Inc.

Spineology Rampart One Standard ALIF Device

 

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory