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 Sc Medica.
77
Total
77
Cleared
121d
Avg days
1997
Since
77 devices
Cleared
Nov 20, 2019
AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System
Medos International SARL
Orthopedic
90d
Cleared
Oct 11, 2019
PMT Facet Screw
Providence Medical Technology, Inc.
Orthopedic
294d
Cleared
Jun 28, 2018
FaSet Fixation System
Huvexel Co. , Ltd.
Orthopedic
100d
Cleared
Jan 03, 2018
Facet Screw Fixation System
U&I Corporation
Orthopedic
93d
Cleared
Aug 22, 2003
STRYKER SPINE OASYS BONE SCREW
Howmedica Osteonics Corp.
Orthopedic
86d