OrthoLogic files PMA (premarket approval) supplement for spinal stimulator:
This article was originally published in Clinica
Executive Summary
OrthoLogic has filed a premarket approval (PMA) supplement with the US FDA for its SpinaLogic-1000 non-invasive device which stimulates spinal fusion. The device uses combined magnetic field technology to treat patients with spinal fusion in 30-minute daily treatments. If approved, it will be the Tempe, Arizona-based company's first entry into the spinal fusion market. The new supplement is based on the company's PMA for its OL-1000 bone growth stimulator, which received FDA approval in 1994.