2016-05384: Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems
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The Food and Drug Administration (FDA or Agency) is proposing to classify posterior cervical screw systems into class II (special controls) and to continue to require premarket notification to provide a reasonable assurance of safety and effectiveness of the device. A posterior cervical screw system is a prescription device 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 these devices from currently classified pedicle screw spinal systems cleared for use in other spinal regions.
The agency’s own summary, as published.
What this changes
Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.
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