Life Spine(R) Announces FDA Clearance Of FS3(TM) Minimally Invasive Spinal System

Main Category: Bones / Orthopaedics
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 10 Jul 2009 - 2:00 PDT

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Life Spine announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the FS3 Minimally Invasive Spinal System.

Available for nationwide release this August, the FS3 MIS Spinal System offers cannulated wire guided Minimally Invasive Surgery implants and instrumentation to accommodate a range of patient pathologies through a percutaneous or open approach. Intuitive design allows for fast, reliable, and reproducible access and implantation with minimal exposure and tissue dissection.

Michael S. Butler, Life Spine's President and CEO stated, "This is the first of many new minimally invasive innovations that Life Spine is bringing to market over the next six months. In addition to our already diverse product offering, the FS3 posterior MIS screw system marks our fourteenth product to market and further strengthens our position as an engineering centric operation focused on bringing surgeon concepts to life."

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.

Source: Life Spine