MRW

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
25–48 of 78
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
K192281
Medos International SARL
Orthopedic · 90d
Cleared Oct 11, 2019
PMT Facet Screw
K183589
Providence Medical Technology, Inc.
Orthopedic · 294d
Cleared Jun 28, 2018
FaSet Fixation System
K180729
Huvexel Co. , Ltd.
Orthopedic · 100d
Cleared Jan 03, 2018
Facet Screw Fixation System
K173198
U&I Corporation
Orthopedic · 93d
Cleared Jan 16, 2015
Proficient (TM) Facet Screw Spine System
K142980
Spine Wave, Inc.
Orthopedic · 93d
Cleared Nov 28, 2012
ILLICO FS FACET FIXATION SYSTEM
K123218
Alphatec Spine, Inc.
Orthopedic · 44d
Cleared Nov 28, 2011
RAPTOR FACET FIXATION SYSTEM
K110170
Alphatec Spine, Inc.
Orthopedic · 312d
Cleared Nov 21, 2011
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
K112097
Exactech, Inc.
Orthopedic · 122d
Cleared Nov 15, 2010
VIPER F2 FACET FIXATION SYSTEM
K101762
Depuy Spine, Inc.
Orthopedic · 146d
Cleared Jul 15, 2010
FACET SCREW SYSTEM
K101284
Nuvasive, Inc.
Orthopedic · 69d
Cleared Nov 09, 2009
SPINEOLOGY FACET SCREW
K092464
Spineology, Inc.
Orthopedic · 90d
Cleared Jul 14, 2009
ZYFUSE FACET FIXATION SYSTEM
K090952
Globus Medical, Inc.
Orthopedic · 102d
Cleared Jun 26, 2009
LIFE SPINE FACET SCREW SPINAL SYSTEM
K090865
Life Spine
Orthopedic · 88d
Cleared Feb 06, 2009
CORRIDOR FIXATION SYSTEM
K083442
Globus Medical, Inc.
Orthopedic · 78d
Cleared Aug 22, 2003
STRYKER SPINE OASYS BONE SCREW
K031657
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Jul 24, 2002
MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM
K021705
Medtronic Sofamor Danek, Inc.
Orthopedic · 62d
Cleared Mar 12, 2002
NUVASIVE TRIAD FACET SCREW SYSTEM
K020411
Nuvasive, Inc.
Orthopedic · 33d
Cleared Dec 19, 2001
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K013829
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Nov 16, 2001
DISCOVERY FACET SCREW FIXATION SYSTEM
K012773
Depuyacromed
Orthopedic · 88d
Cleared Jan 17, 2001
TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K003928
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jul 25, 2000
NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW
K001323
Nuvasive, Inc.
Orthopedic · 90d
Cleared Apr 18, 2000
NUVASIVE TOWNLEY FACET SCREW
K994308
Nuvasive, Inc.
Orthopedic · 119d
Cleared Feb 28, 1997
TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM
K953076
Sofamor Danek USA,Inc.
Orthopedic · 609d