FDA Product Code MRW: System, Facet Screw Spinal Device
FDA product code MRW covers facet screw spinal systems used for posterior spinal fixation.
These implants are inserted into the facet joints of the spine to provide segmental stabilization as an alternative or adjunct to pedicle screw fixation. Facet screws offer a less invasive fixation option for selected spinal fusion procedures.
MRW devices are reviewed by the FDA Orthopedic panel.
Leading manufacturers include Providence Medical Technology, Inc., SurGenTec, LLC and Nuvasive, Inc..
FDA 510(k) Cleared System, Facet Screw Spinal Device Devices (Product Code MRW)
About Product Code MRW - Regulatory Context
510(k) Submission Activity
78 total 510(k) submissions under product code MRW since 1997, with 78 receiving FDA clearance (average review time: 120 days).
Submission volume has remained relatively stable over the observed period, with 12 submissions in the last 24 months.
FDA 510(k) Review Time - MRW Product Code
FDA review times for MRW submissions have been consistent, averaging 129 days recently vs 118 days historically.
MRW devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →