KWP · Class II · 21 CFR 888.3050

FDA Product Code KWP: Appliance, Fixation, Spinal Interlaminal

Leading manufacturers include Medtronic Sofamor Danek, Medtronic Sofamor Danek, Inc. and Synthes (Usa).

430
Total
430
Cleared
130d
Avg days
1978
Since
430 devices
49–72 of 430
Cleared Dec 11, 2008
MESA AND RANGE SPINAL SYSTEMS
K082769
K2m, Inc.
Orthopedic · 80d
Cleared Nov 14, 2008
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
K081906
Globus Medical, Inc.
Orthopedic · 134d
Cleared Nov 14, 2008
VERTEX RECONSTRUCTION SYSTEM
K083071
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Oct 10, 2008
CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS
K081107
K2m, Inc.
Orthopedic · 175d
Cleared Jun 11, 2008
VERTEX RECONSTRUCTION SYSTEM
K081297
Medtronic Sofamor Danek
Orthopedic · 35d
Cleared Apr 18, 2008
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K080805
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Mar 28, 2008
SPINOUS PROCESS PLATE SYSTEM
K073278
Nuvasive, Inc.
Orthopedic · 128d
Cleared Mar 13, 2008
BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM
K080394
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Feb 14, 2008
BLACKSTONE ASCENT MULTIAXIAL SCREWS
K073420
Blackstone Medical, Inc.
Orthopedic · 71d
Cleared Jan 24, 2008
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR
K073654
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Dec 11, 2007
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K071942
Medtronic Sofamor Danek
Orthopedic · 151d
Cleared Oct 24, 2007
ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM
K072081
Alphatec Spine, Inc.
Orthopedic · 86d
Cleared Oct 15, 2007
TRAVERSE OCT SPINAL FIXATION SYSTEM
K062447
Medtronic Sofamor Danek, Inc.
Orthopedic · 419d
Cleared Oct 05, 2007
MODIFICATION TO OASYS SYSTEM
K072568
Stryker Spine
Orthopedic · 23d
Cleared Sep 14, 2007
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K070742
Medtronic Sofamor Danek
Orthopedic · 182d
Cleared Apr 10, 2007
EXPEDIUM SFX CROSS CONNECTOR SYSTEM
K070300
Depuy Spine, Inc.
Orthopedic · 69d
Cleared Sep 08, 2006
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061591
Medtronic Sofamor Danek, Inc.
Orthopedic · 92d
Cleared Aug 11, 2006
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061579
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared Feb 13, 2006
BASIS SPINAL SYSTEM
K060081
Medtronic Sofamor Danek
Orthopedic · 34d
Cleared Nov 10, 2005
SOLANAS POSTERIOR STABILIZATION SYSTEM
K052201
Alphatec Spine, Inc.
Orthopedic · 90d
Cleared Oct 21, 2005
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K052734
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Sep 28, 2005
EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS
K052131
Depuy Spine, Inc.
Orthopedic · 54d
Cleared Sep 23, 2005
SYNTHES PANGEA SYSTEM
K052123
Synthes (Usa)
Orthopedic · 49d
Cleared Sep 23, 2005
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K052376
Medtronic Sofamor Danek
Orthopedic · 24d