The FDA announced it issued a final rule which classifies posterior cervical screw systems into class II, devices with special controls, and is effective as of May 1, 2019.
According to the final rule published by the FDA, device sponsors will continue to need premarket notification 510(k) to offer assurance of device safety and effectiveness. Manufactures reportedly must comply with special controls for materials, durability, biocompatibility, sterility and labeling.
As stated in the FDA final rule, “The term ‘posterior cervical screw systems’ is used to distinguish these devices from currently classified thoracolumbosacral pedicle screw systems for use in other spinal regions.”
Re ference s :
www.federalregister.gov/documents/2019/04/01/2019-06024/medical-devices-orthopedic-devices-classification-of-posterior-cervical-screw-systems?utm_campaign=2019-04-01 CDRH New&utm_medium=email&utm_source=Eloqua