Intellirod Spine Receives First-Ever Spine FDA De Novo Approval (press release)
MCRA Assists Intellirod Spine™ with 1st ever Spine De Novo Decision by the FDA
Intellirod Spine, the spinal sensor technology company developing wearable, disposable and implantable wireless sensors for spine surgeons and their patients, obtained FDA De Novo approval for its revolutionary disposable spinal rod strain sensor, the LOADPRO. The device clamps onto a standard 5.5mm rod for use in monitoring rod strain during a kyphotic correction surgery. This initial approval is for use of LOADPRO with the FORTEX pedicle screw system from Xtant Medical.
“We are delighted to be the first device in this new FDA product category for spine to give the surgeon unprecedented new information about how much strain is on their rods as they correct a deformity”Tweet this
“We are delighted to be the first device in this new FDA product category for spine to give the surgeon unprecedented new information about how much strain is on their rods as they correct a deformity,” says Mr. Ric Navarro, CEO of Intellirod. “Now the surgeon can quantify their tactile feel and be knowledgeable of the strain level as it relates to...
