510(k) for Clarus Medical Systems' spinal surgery system:
This article was originally published in Clinica
Executive Summary
Clarus Medical Systems of Minneapolis, Minnesota, has received 510(k) clearance from the FDA for its SITEtrac minimally invasive spinal surgery system. Designed as an alternative to open lumbar spine surgery, the system consists of tubular dilators, retractors and a high-resolution endoscope. The system is reusable and does not require any specialised instruments.