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 Dec 16, 2019
CORRIDOR Fixation System
K192744
Globus Medical, Inc.
Orthopedic · 77d
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 Feb 16, 2017
ALLY™ Facet Screws
K163374
Providence Medical Technology, Inc.
Orthopedic · 77d
Cleared Aug 04, 2016
FacetBRIDGE® System
K161798
Ldr Spine USA, Inc.
Orthopedic · 35d
Cleared Jan 25, 2016
FacetBRIDGE System
K152137
Ldr Spine USA
Orthopedic · 178d
Cleared Apr 28, 2015
Facet-Link Stabilization Platform
K150223
Facet-Link, Inc.
Orthopedic · 88d
Cleared Jan 16, 2015
Proficient (TM) Facet Screw Spine System
K142980
Spine Wave, Inc.
Orthopedic · 93d
Cleared Nov 18, 2013
INTEGRA FACET FIXATION SYSTEM
K132859
Seaspine, Inc.
Orthopedic · 67d
Cleared Oct 28, 2013
SPECTRUM SPINE FENESTRATED FACET SCREW SYSTEM
K132126
Spectrum Spine, LLC
Orthopedic · 110d
Cleared Aug 09, 2013
FACET SCREW SYSTEM
K130863
Spinal USA
Orthopedic · 134d
Cleared Jul 12, 2013
FACET FIXX
K131417
Nexxt Spine, LLC
Orthopedic · 57d
Cleared May 03, 2013
KOMPREDA
K120597
Custom Spine, Inc.
Orthopedic · 430d
Cleared May 01, 2013
ZYGAFIX SPINAL FACET SCREW SYSTEM
K123932
X-Spine Systems, Inc.
Orthopedic · 132d
Cleared Feb 28, 2013
FACET SCREW SYSTEM
K123497
Facet-Link, Inc.
Orthopedic · 107d
Cleared Nov 28, 2012
ILLICO FS FACET FIXATION SYSTEM
K123218
Alphatec Spine, Inc.
Orthopedic · 44d
Cleared Oct 23, 2012
RESOLUTE FACET SCREW SYSTEM
K121551
Neurostructures, LLC
Orthopedic · 151d
Cleared Oct 19, 2012
VENUS FACET SCREW SYSTEM
K120340
Apollo Spine, Inc.
Orthopedic · 259d
Cleared Sep 20, 2012
Typhoon(TM) Facet Screw Fixation System
K121850
Choicespine, LP
Orthopedic · 87d
Cleared Dec 06, 2011
SPARTAN S3 FACET SYSTEM
K113011
Amendia, Inc.
Orthopedic · 56d
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