Spinal Simplicity has received a Health Canada Medical Device License for its Minuteman G3 and HA G3 spinal implants.
The Minuteman is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion for degenerative disc disease, spondylolisthesis, trauma and tumour. The device is intended for use with bone graft material and is not intended for stand-alone use.
Todd Moseley, co-founder and chief executive officer of Spinal Simplicity, states “I am pleased to announce that our flagship products, the Minuteman G3 minimally invasive fusion plate and the HA Minuteman G3 minimally invasive fusion plate, have received a Class 3 license from Health Canada.”
Spinal Simplicity received US Food and Drug Administration (FDA) clearance on the Minuteman G3 implant in January 2015, and clearance on the HA Minuteman G3 implant in August 2015. The first Minuteman received its European CE mark approval in May 2011. With successful receipt of the Canadian Medical Device License, Spinal Simplicity will enter the Canadian market.