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..
78
Total
78
Cleared
120d
Avg days
1997
Since
78 devices
Cleared
Nov 15, 2010
VIPER F2 FACET FIXATION SYSTEM
Depuy Spine, Inc.
Orthopedic
146d
Cleared
Sep 30, 2010
PRIMALOK FACET FIXATION SYSTEM
Osteomed LP
Orthopedic
35d
Cleared
Aug 16, 2010
LANX FACET SCREW SYSTEM
Lanx, Inc.
Orthopedic
94d
Cleared
Jul 15, 2010
FACET SCREW SYSTEM
Nuvasive, Inc.
Orthopedic
69d
Cleared
May 21, 2010
FIXCET SPINAL FACET SCREW SYSTEM
X-Spine Systems, Inc.
Orthopedic
121d
Cleared
Nov 17, 2009
SPARTAN S3 FACET SYSTEM
Amendia, Inc.
Orthopedic
89d
Cleared
Nov 09, 2009
SPINEOLOGY FACET SCREW
Spineology, Inc.
Orthopedic
90d
Cleared
Jul 14, 2009
ZYFUSE FACET FIXATION SYSTEM
Globus Medical, Inc.
Orthopedic
102d
Cleared
Jun 26, 2009
LIFE SPINE FACET SCREW SPINAL SYSTEM
Life Spine
Orthopedic
88d
Cleared
Feb 06, 2009
CORRIDOR FIXATION SYSTEM
Globus Medical, Inc.
Orthopedic
78d
Cleared
Jan 16, 2008
CHAMELEON FIXATION SYSTEM
Spinefrontier, Inc.
Orthopedic
239d
Cleared
Feb 18, 2005
4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N
Triage Medical, Inc.
Orthopedic
74d
Cleared
Aug 22, 2003
STRYKER SPINE OASYS BONE SCREW
Howmedica Osteonics Corp.
Orthopedic
86d
Cleared
Jul 24, 2002
MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM
Medtronic Sofamor Danek, Inc.
Orthopedic
62d
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