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..
79
Total
79
Cleared
119d
Avg days
1997
Since
79 devices
Cleared
Mar 12, 2002
NUVASIVE TRIAD FACET SCREW SYSTEM
Nuvasive, Inc.
Orthopedic
33d
Cleared
Dec 19, 2001
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
Medtronic Sofamor Danek, Inc.
Orthopedic
30d
Cleared
Nov 16, 2001
DISCOVERY FACET SCREW FIXATION SYSTEM
Depuyacromed
Orthopedic
88d
Cleared
Jan 17, 2001
TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
Medtronic Sofamor Danek, Inc.
Orthopedic
28d
Cleared
Jul 25, 2000
NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW
Nuvasive, Inc.
Orthopedic
90d
Cleared
Apr 18, 2000
NUVASIVE TOWNLEY FACET SCREW
Nuvasive, Inc.
Orthopedic
119d
Cleared
Feb 28, 1997
TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM
Sofamor Danek USA,Inc.
Orthopedic
609d