Latest medtech regulatory news

Lateral expandable spacer system, plate system

Life Spine received clearance from the U.S. Food & Drug Administration (FDA) to market the TruLift Lateral Expandable Spacer System and Lateral Plate System. Using expandable technology and robust plating options, TruLift Lateral and Lateral Plate System provide physicians with unique possibilities for patient care. TruLift Lateral is offered in a range of sizes and footprints and can be expanded to the desired height (8mm to 16mm) to suit patients' individual pathology and anatomical conditions. The 1-screw, 2-screw, and 4-screw Lateral Plates provide immediate stabilization and fixation of the lumbar spine and may optionally attach to the TruLift Lateral Expandable Spacer.

http://www.lifespine.com

TruLift Lateral features, benefits:

• Post-packable & repositionable, in-situ
• Up to 8mm of in-situ expansion, disc height restoration
• Minimized impaction, preserved end plate integrity, designed to reduce psoas irritation

Lateral Plates features, benefits:

• Audible, tactile, visual confirmation of cam-locking mechanism provides confidence in preventing screw back-out
• Plate teeth provide intraoperative stabilization, prevents postoperative plate rotation
• Optional connection screw to fasten plate to interbody minimizes risk of implant migration