News: FDA clears Life Spine’s Pro-Link Ti cervical spacer
Life Spine said today that it won 510(k) clearance from the FDA for its Pro-Link Ti cervical spacer.
The Huntley, Ill.-based company said the product is slated for full release by the end of 2016, joining a portfolio of devices that Life Spine launched this year.
The spacers allow for the fusion of adjacent segments of spine without removing an existing anterior cervical plate. The locking plate provides security against screw backout, without disturbing the surrounding tissue, according to Life Spine.
“Pro-Link Ti offers a low-profile, stand-alone cervical interbody with our groundbreaking Osseo-Loc technology. Osseo-Loc is a proprietary surface treatment for titanium with 500-600 microns of porosity, which helps create an environment for potential bone growth,” COO Rich Mueller said in prepared remarks. “Due to the structural integrity of titanium, we were also able to include lateral graft windows for maximum bone graft volume and visibility.”
Life Spine in March won 510(k) clearance for its Prolift expandable interbody fusion system and in June the FDA approved its subtalar arthroereisis implant.