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..

79
Total
79
Cleared
119d
Avg days
1997
Since
79 devices
49–72 of 79
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 Oct 22, 2010
KYPHON ANCHOR FACET SCREW SYSTEM
K101765
Medtronic Spine, LLC
Orthopedic · 121d
Cleared Sep 30, 2010
PRIMALOK FACET FIXATION SYSTEM
K102438
Osteomed LP
Orthopedic · 35d
Cleared Aug 16, 2010
LANX FACET SCREW SYSTEM
K101364
Lanx, Inc.
Orthopedic · 94d
Cleared Jul 15, 2010
FACET SCREW SYSTEM
K101284
Nuvasive, Inc.
Orthopedic · 69d
Cleared May 21, 2010
FIXCET SPINAL FACET SCREW SYSTEM
K100154
X-Spine Systems, Inc.
Orthopedic · 121d
Cleared Nov 17, 2009
SPARTAN S3 FACET SYSTEM
K092568
Amendia, Inc.
Orthopedic · 89d
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 Jun 11, 2009
PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER
K090767
Interventional Spine, Inc.
Orthopedic · 80d
Cleared Feb 06, 2009
CORRIDOR FIXATION SYSTEM
K083442
Globus Medical, Inc.
Orthopedic · 78d
Cleared Dec 12, 2008
SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT
K082795
Interventional Spine, Inc.
Orthopedic · 80d
Cleared Mar 11, 2008
TRANS1 FACET SCREW
K073515
Trans1 Incorporated
Orthopedic · 88d
Cleared Jan 16, 2008
CHAMELEON FIXATION SYSTEM
K071420
Spinefrontier, Inc.
Orthopedic · 239d
Cleared Sep 14, 2006
DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02
K062391
Triage Medical, Inc.
Orthopedic · 29d
Cleared Jun 19, 2006
US SPINE FACET FIXATION SYSTEM
K061041
Us Spine
Orthopedic · 66d
Cleared Oct 17, 2005
3.8MM CS FACET COMPRESSION DEVICE
K052043
Triage Medical, Inc.
Orthopedic · 81d
Cleared Sep 26, 2005
TRANS1 FACET SCREWS
K051856
Trans1 Incorporated
Orthopedic · 80d
Cleared Aug 05, 2005
4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040
K051949
Triage Medical, Inc.
Orthopedic · 21d
Cleared Feb 18, 2005
4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N
K043351
Triage Medical, Inc.
Orthopedic · 74d
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