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Medical Devices / Submissions and Approvals

FDA Issues Final Rule on Posterior Cervical Screw Systems

April 1, 2019
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The FDA released a final rule to classify posterior cervical screw systems as Class II (special controls) and to continue to require sponsors to submit a premarket notification to provide a reasonable assurance of safety and effectiveness of the device.

Posterior cervical screw systems are used to provide immobilization and stabilization in the cervical spine as an adjunct to spinal fusion surgery.

The term “posterior cervical screw systems” is used to distinguish the devices from currently classified thoracolumbosacral pedicle screw systems for use in other spinal regions.

Manufacturers must comply with five special controls for materials, durability, biocompatibity, sterility and labeling.

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