The US Food and Drug Administration (FDA) has granted 510(k) marketing clearance for medical device firm Life Spine’s Gruve Anterior Cervical Plate system.
Life Spine designs, develops, manufactures and markets products for the surgical treatment of spinal disorders.
The Gruve Anterior Cervical Plate allows for extreme bone screw angulation and large graft windows, in addition to a tactile and visual confirmation of the locking mechanism during final screw placement.
Gruve, which is the company’s latest addition cervical platform, marks the eighth cervical plating option for spine surgeons worldwide.
Life Spine sales executive vice-president Joe Loy said: "Our comprehensive cervical portfolio reinforces Life Spine’s commitment to providing single-source, cohesive procedural solutions to our customers."
The existing anterior cervical product offering consists of five static systems NEO, NEO-SL, NEO-UL, IRIS and PRO-LINK, and two internally dynamising systems Kinetic and Kinetic-SL.
The company noted the limited release of Gruve is scheduled at the beginning of 2016 with a full product release expected in the second quarter of next year.
In March, the company obtained 510(k) approval from the FDA for 40 transition connector implants. Approved implants include Conquest, Avatar and Nautilus Thoracolumbar Screw systems and Solistice Occipito-Cervico-Thoracic system.
Based in Huntley, Illinois, Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through new design, high quality standards, and technologically advanced manufacturing platforms.