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Reimbursement / Regulatory

Intellirod Spine Gains FDA De Novo Clearance for LOADPRO Spine Sensing System -

Intellirod Spine gained FDA de novo clearance for the LOADPRO® disposable spinal rod strain sensor. The device clamps to a 5.5mm rod to monitor rod strain during kyphotic correction. This initial approval is for use of LOADPRO with Xtant Medical's FORTEX pedicle screw; first launches of the product are slated for Ohio and Kentucky. Expanded commercial launch sites and clearance for use with other pedice screw systems are in development. This reportedly represents the first de novo clearance for a spine product. (Intellirod Spine, 4/1/19)