Life Spine Announces FDA 510(k) Clearance for the ARx® SAI Spinal Fixation System
2024年8月1日 - 12:25AM
ビジネスワイヤ(英語)
Life Spine, a medical device company that designs, develops,
manufactures and markets products for the surgical treatment of
spinal disorders, announced today that it has received clearance
from the U.S. Food & Drug Administration (FDA) to market the
ARx SAI (Sacral Alar Iliac) Spinal Fixation System.
The ARx SAI Spinal Fixation System represents the next
generation in posterior fixation technology. This system can be
utilized through a Sacral Alar Iliac trajectory in S1 and/or S2,
providing maximum fixation across the Sacroiliac Joint. The system
features versatile implants paired with streamlined ergonomic
instrumentation, allowing for the construction of customized
solutions tailored to each patient's specific pathology while
maintaining ease of use. The screw shank is based on Life Spine's
highly successful SImpact® SI self-harvesting screw design, which
is self-drilling and recruits autograft during insertion.
"ARx SAI advances our commitment to innovation, positioning us
among the pioneering spine companies to offer an SAI screw within
our Lumbar Spinal Fixation Systems portfolio. ARx SAI delivers
customizable solutions tailored to each patient, ensuring ease of
use and versatile trajectory options," said Mariusz Knap, Senior
Vice President of Sales and Marketing.
Key Features and Benefits of the ARx SAI Spinal Fixation
System:
- Self-drilling screws: Eliminate surgical steps,
increasing efficiency and saving time
- Self-harvesting design: Packs bone into fenestrations
during insertion
- Low-profile Cobalt Chrome tulip head: Provides greater
strength and supports patients of all sizes
- Universal T25 hexalobe drive: Ensures ease of use and
simplicity
About Life Spine, Inc.
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. For
more information, please visit: http://www.lifespine.com.
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Mr. Omar Faruqi Chief Financial Officer ofaruqi@lifespine.com
847-884-6117