FDA 510(k) for Life Spine TruLift Lateral Expandable Spacer

Life Spine received FDA 510(k) clearance to market the TruLift Lateral Expandable Spacer and Lateral Plate.

TruLift Lateral is offered in a range of sizes and footprints and can be expanded to the desired height (8mm to 16mm) to suit the patient’s 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.

TruLift Lateral Features and Benefits:

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

Lateral Plate Features and Benefits:

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

Source: Life Spine