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Precision Spine receives FDA approval for pedicle screw systems

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Precision Spine Inc. announced it has received FDA approval of its Reform Modular and hydroxyapatite Coated Pedicle Screw Systems.

The Reform Modular Pedicle Screw System feature a cobalt chrome tulip with a proximal tapered triple lead thread. According to a company press release, the top-loading, multiple component, posterior spinal fixation system consists of pedicle screws, rods, cross-connectors, locking cap screws, dominoes, hooks and lateral offsets. The system is intended to provide immobilization and stabilization of spinal segments.

The patent-pending hydroxyapatite (HA) Coated Pedicle Screw Systems have an HA coating applied to the screw threads. The HA coating is designed to improve the amount of fixation between the pedicle screw and the surrounding bone in osteoporotic patients.

Reference: www.precisionspineinc.com