Zavation’s Pedicle Screw Set Cleared by FDA

June 18, 2019

The FDA has handed Zavation 510(k) clearance for its pedicle screw system that can be used for single or multiple-level fixations.

The system is made up of polyaxial pedicle screws, cross connectors and rods that come in a variety of diameters and lengths for use in stabilizing and holding in place spinal segments in adult patients.

Zavation’s pedicle screw system is designed as an adjunct to spinal fusion in treating acute and chronic instabilities or deformities of the lumbar, thoracic and sacral spine.

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