Firm Gets Warning Letter for Spinal Screw Design Changes

Allez Spine’s Laguna Pedicle Screw System, a 510(k) spinal fixation system substantially equivalent to Medtronic’s CD Horizon spinal system, is adulterated because the firm made significant changes to the device without submitting the requisite premarket notification, according to an FDA warning letter. The company said it plans to release a revised design of the system, which would have a new 510(k).