Precision Spine wins 510(k) for pedicle screw

Precision Spine said today it won FDA 510(k) clearance for its reform modular and hydroxyapatite coated pedicle screw systems.

The modular screw system is designed with a cobalt chrome tulip and proximal tapered triple lead thread designed to enhance pull-out strength and increase visibility, the Parsippany, N.J.-based company said

“The Reform system is one of the most comprehensive and versatile top loading pedicle screw systems available. With the addition of the Modular and HA coated products, Reform now offers more ways to help surgeons best meet their patients’ complex spinal pathologies,” exec veep of operations Chris DeNicola said in a press release

The hydroxyapatite coating is designed to ehance fixation between screw and bone in osteoporotic patients, the company said.

 

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