Life Spine Announces Additional 510(k) Clearance for SImpact® SI Joint Fixation System
March 29, 2022
HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that is has received clearance from the U.S. Food & Drug Administration (FDA) to market SImpact SI Joint Fixation System for Posterior-Oblique approaches.
Whether the physician is performing a Direct Lateral or the newly cleared Posterior-Oblique, SImpact is uniquely designed to allow the same screws and same instrumentation to be utilized. This additional clearance enables physicians to offer the appropriate approach to suit the patient’s anatomy and pathology.
“SImpact offers a complete solution for SI Joint Fixation. This additional clearance furthers our SI portfolio by expanding the capabilities of the system to be utilized in a Posterior-Oblique approach” said Mariusz Knap, Sr Vice President of Marketing. “The system offers a variety of configurations including 8mm Lag screw, 12mm SImpact screw and a 14.5mm Revision screw making it one of the most robust SI systems on the market.”
SImpact Features and Benefits:
- Diameters: Lag – 8mm, SImpact – 12mm and Revision – 14.5mm
- Self-Drilling and Self-Harvesting Screw Design
- Anti-Rotational Sleeve Designed to Prevent Screw Back-out
About 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 Huntley, Illinois. For more information, please visit: http://www.lifespine.com and/or www.sijointfixation.com.
Contacts
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117
