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 Apr 18, 2008
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K080805
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Apr 17, 2008
SIERRA
K072729
Seaspine, Inc.
Orthopedic · 204d
Cleared Apr 16, 2008
SIERRA SYSTEM
K080526
Seaspine, Inc.
Orthopedic · 50d
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 13, 2007
ISSYS LP SPINAL FIXATION SYSTEM
K072866
Custom Spine, Inc.
Orthopedic · 69d
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 15, 2007
LANX DEFORMITY SYSTEM
K071633
Lanx, LLC
Orthopedic · 62d
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 Jul 20, 2007
GSO GS1 SPINAL SYSTEM
K070966
Gold Standard Orthopaedics, LLC
Orthopedic · 106d
Cleared May 30, 2007
THEKEN ATOLL CERVICO-THORACIC SYSTEM
K070638
Theken Spine, LLC
Orthopedic · 84d
Cleared May 25, 2007
ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM
K061943
Anatomica AB
Orthopedic · 319d
Cleared Apr 10, 2007
EXPEDIUM SFX CROSS CONNECTOR SYSTEM
K070300
Depuy Spine, Inc.
Orthopedic · 69d
Cleared Jan 16, 2007
C-JAWS CERVICAL COMPRESSIVE MINI FRAME
K062181
Medicrea Technologies
Orthopedic · 169d
Cleared Dec 26, 2006
LTD POLYAXIAL FIXATION SYSTEM
K062785
Us Spine
Orthopedic · 99d
Cleared Dec 22, 2006
APEX SPINE SYSTEM
K062513
Spinecraft, Inc.
Orthopedic · 116d
Cleared Sep 08, 2006
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061591
Medtronic Sofamor Danek, Inc.
Orthopedic · 92d