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Life Spine gets FDA 510(k) clearance for PLATEAU-LO insert and rotate spacer system

Published 21 March 2018

Life Spine has secured 510(k) marketing clearance from the US Food and Drug Administration (FDA) for the PLATEAU-LO Insert and Rotate Spacer System.

“PLATEAU-LO is my go-to spacer for micro-invasive lumbar interbody fusions. The oblique lordosis and vast array of footprints cater to the wide variety of patient anatomies I see in my practice. I also find that the bulleted tip allows for very simple insertion, and the insert and rotate feature allows for restoration of disc height. These features are essential for good patient outcomes,” said Rebecca Kuo, MD of Joliet, IL.

Life Spine marketing and business development vice president Mariusz Knap said: “PLATEAU-LO is another great addition to our already robust interbody platform.

“By combining PLATEAU-LO with our AVATAR® Percutaneous Screw System, and the CENTRIC®-T Pedicle-Based Retractor System it shows our keen interest in innovation around micro-invasive procedures and providing our customers with multiple options for optimal patient care.”

PLATEAU-LO is available in PEEK material and is offered in 7° and 12° lordosis and multiple footprints options.

Key Features and Benefits of the system are:

Chamfered corners allow for ease of insertion and distraction

Oblique lordosis to better match patient anatomies and pathologies

Bullet tip simplifies insertion

Large, open graft windows maximize visibility and bone graft containment

Aggressive tooth pattern prevents graft migration

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 Huntley, Illinois.



Source: Company Press Release