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
97–120 of 430
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 Aug 08, 2007
LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM
K070341
Ldr Spine USA
Orthopedic · 183d
Cleared Aug 06, 2007
POLARIS BE RODS
K071377
Biomet Spine
Orthopedic · 81d
Cleared May 30, 2007
THEKEN ATOLL CERVICO-THORACIC SYSTEM
K070638
Theken Spine, LLC
Orthopedic · 84d
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 Sep 06, 2006
SYNTHES OC FUSION SYSTEM
K053418
Synthes Spine Co.Lp
Orthopedic · 272d
Cleared Aug 11, 2006
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061579
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared Apr 18, 2006
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K060683
Endius, Inc.
Orthopedic · 34d
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
Cleared Sep 23, 2005
VERTEX RECONSTRUCTION SYSTEM
K052402
Medtronic Sofamor Danek
Orthopedic · 22d
Cleared Sep 08, 2005
MODIFICATION TO XIA SPINAL SYSTEM
K052181
Stryker Spine
Orthopedic · 29d
Cleared Aug 23, 2005
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K052180
Medtronic Sofamor Danek
Orthopedic · 13d
Cleared Aug 18, 2005
MODIFICATION TO: XIA STAINLESS STEEL SYSTEM
K051973
Stryker Spine
Orthopedic · 28d