Tag: FDA Approval
Approval of SENTINEL OCT System
by admin on Sep.30, 2009, under Biotech Stock, FDA News
Sentinel OCT System allows surgeons to treat complex procedures from the occiput to the thoracic spine.
HOFFMAN ESTATES: Life Spine announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing approval to the SENTINEL Occipito-Cervico-Thoracic (OCT) System.
The SENTINEL OCT System provides rigid stabilization and promotes fusion from the occiput to thoracic spine, and features streamlined implants and instruments to address complicated procedures. Polyaxial screws are available in multiple diameters and lengths, and offer a generous cone angulation, which simplifies alignment with the rod and minimizes rod contouring.
The addition of the SENTINEL OCT System to the current broad product offering is a watershed event providing the ability to offer surgeons a full range of solutions to address spinal pathologies from the occiput to the sacrum. The SENTINEL OCT System makes its mark as the twentieth 510(k) approval to date for Life Spine.
Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Hoffman Estates, Illinois. For more information, please visit http://www.lifespine.com.
