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 SurGenTec, LLC, Providence Medical Technology, Inc. and Sc Medica.
FDA 510(k) Cleared System, Facet Screw Spinal Device Devices (Product Code MRW)
About Product Code MRW - Regulatory Context
510(k) Submission Activity
76 total 510(k) submissions under product code MRW since 1997, with 76 receiving FDA clearance (average review time: 120 days).
Submission volume has increased in recent years - 13 submissions in the last 24 months compared to 8 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for MRW submissions have been consistent, averaging 110 days recently vs 122 days historically.
MRW devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →