Precision Spine receives 510(k) clearance for cervical plate system
Precision Spine Inc. announced that Spinal USA Inc., its wholly owned subsidiary, received 510(k) clearance for the Simplicity Solo Anterior Cervical Plate System, for anterior cervical fixation to the cervical spine C2-C7 for degenerative disc disease, trauma, tumors, deformity, pseudarthrosis, failed previous fusion, spondylolisthesis and spinal stenosis.
Designed to have a simple and secure locking mechanism that accommodates visual locking confirmation, the anterior cervical plate system offers one of the slimmest profile plates available, according to a press release. It is comprised of one of two level plates and 4.5-mm fixed and variable screws, and provides and ergonomic color coded instrument set.
“[Simplicity Solo] will provide surgeons with an exciting new fixation system for the cervical spine, offering potential benefits over existing, traditional cervical plating systems,” Rich Dickerson, president of Precision Spine, stated. “We also believe this produce will have application in the expanding same-day surgery market segment.”