Jupiter, FL, September 15, 2011 –(PR.com)– Captiva Spine, Inc., a medical device organization dedicated to developing and distributing spinal technologies in the US and internationally, today announced that it has received 510(k) clearance from the U.S. Food and Drug administration (FDA) to market the CapLOX II™ Spinal System, a top-loading pedicle screw system including screws, set screws, rods, and cross connectors for the thoracic, lumbar and sacral spine.
CapLOX II™ is designed specifically to provide exceptional mechanical performance, and improved control. This is achieved through enhanced compatibility of the instrumentation with the large selection of implants. The pedicle screws will be offered in cannulated and non-cannulated versions for increased clinical options.
“The FDA clearance of this new system validates our ability to respond to our surgeon customers’ growing demand for comprehensive, reliable and versatile spinal systems, while responding to the hospitals’ needs to control costs,” stated Dale Mitchell, Captiva Spine’s President and Founder. Mitchell added, “This follows our recent 510(k) FDA clearance of the FuseLOX™ Cervical Interbody Fusion Device, which is manufactured using Invibio’s PEEK-Optima® polymer material.”
About Captiva Spine, Inc.
Founded in 2007, Captiva Spine is a privately owned medical devices organization headquartered in Jupiter, Florida. The company’s mission is to provide the market place with a comprehensive range of reliable high quality spinal technologies. Our core competency resides in our ability to understand the reality of the operating room, allowing the organization to identify and develop tangible spinal solutions. Captiva Spine markets a full range of fusion technologies in the US and Internationally.