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
73–96 of 430
Cleared Aug 17, 2010
PRIMAL OK INTERSPINOUS FUSION SYSTEM
K100354
Osteomed LP
Orthopedic · 186d
Cleared Jun 23, 2010
NUVASIVE VUEPOINT OCT SYSTEM
K093319
Nuvasive, Inc.
Orthopedic · 243d
Cleared Jun 18, 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K100685
Alphatec Spine, Inc.
Orthopedic · 100d
Cleared Apr 15, 2010
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K100191
Lanx, Inc.
Orthopedic · 83d
Cleared Mar 16, 2010
APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER
K092825
Spinecraft, Inc.
Orthopedic · 186d
Cleared Feb 19, 2010
PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
K092295
Pioneer Surgical Technology
Orthopedic · 205d
Cleared Dec 16, 2009
MODIFICATION TO CASPIAN SPINAL SYSTEM
K093534
K2m, Inc.
Orthopedic · 30d
Cleared Nov 24, 2009
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
K092656
Lanx, Inc.
Orthopedic · 88d
Cleared Sep 02, 2009
GSO PCT SPINAL SYSTEM
K091359
Gold Standard Orthopaedics, LLC
Orthopedic · 117d
Cleared Aug 11, 2009
SENTINEL SPINAL SYSTEM
K090343
Life Spine
Orthopedic · 182d
Cleared Aug 06, 2009
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K091365
Medtronic Soafamor Danek
Orthopedic · 90d
Cleared Jul 10, 2009
SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
K091689
Synthes (Usa)
Orthopedic · 30d
Cleared Jun 30, 2009
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM
K090565
Globus Medical, Inc.
Orthopedic · 120d
Cleared Jun 02, 2009
NEXLINK OCT SYSTEM, MODEL 7000 SERIES
K090060
Abbott Spine, Inc.
Orthopedic · 144d
Cleared May 21, 2009
SYNTHES SYNAPSE TRANSCONNECTOR
K090549
Synthes Spine
Orthopedic · 80d
Cleared Apr 17, 2009
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K090714
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Mar 04, 2009
MODIFICATION TO: LANX SPINAL FIXATION SYSTEM
K090252
Lanx, Inc.
Orthopedic · 30d
Cleared Jan 16, 2009
VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K082728
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 120d
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 29, 2008
MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM
K080790
Theken Spine, LLC
Orthopedic · 40d