US sPMA for DJO's bone products:
This article was originally published in Clinica
Executive Summary
DJO has received FDA approval for a PMA supplement covering several new features built into its combined magnetic field (CMF) OL1000 and SpinaLogic bone growth stimulation product lines. The devices employ the San Diego, California firm's CMF technology, which it claims is the only waveform clinically proven to stimulate bone growth. The technology is indicated for use in aiding the healing of fractures in both long bone and primary lumbar spine applications. The new CMF OL1000 and SpinaLogic products are slated for launch in international markets in September.