510(k) approval for steerable PLATEAU Ti System.- Life Spine

Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced that the it has received clearance from the FDA to market the Steerable PLATEAU Ti System. The Steerable PLATEAU Ti System allows for controlled delivery upon insertion to facilitate positioning in the anterior portion of the disc space and features a curved design to match patient anatomy and maximize endplate coverage. Additionally, the spacer was designed to restore patient sagittal balance with lordotic options of 7° and 12°. The Steerable PLATEAU Ti System is available in lengths of 28mm and 32mm and heights ranging from 9mm-14mm in 1mm increments. The system also features Life Spine’s proprietary OSSEO-LOC Surface architecture of 400-600 micron porosity. The Steerable PLATEAU Ti System is complemented by Life Spine’s CENTRIC-T Pedicle-Based Retractor System and the AVATAR MIS Spinal Fixation System. Plateau Ti is a titanium interbody system designed to provide an optimal environment for bone growth in both transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF). It is used to facilitate controlled delivery upon insertion to facilitate positioning in the anterior portion of the disc space..