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
25–48 of 430
Cleared Jun 29, 2012
VERTEX RCCONSTRUCTION SYSTEM
K121191
Medtronic Sofamor Danek, Inc.
Orthopedic · 71d
Cleared Jan 19, 2012
OASYS SPINAL SYSTEM
K111719
Stryker Spine
Orthopedic · 213d
Cleared Jan 12, 2012
CASPIAN
K113654
K2m, Inc.
Orthopedic · 31d
Cleared Jun 02, 2011
BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM
K103205
Alphatec Spine, Inc.
Orthopedic · 213d
Cleared May 24, 2011
ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS)
K111183
Orthofix, Inc.
Orthopedic · 27d
Cleared May 05, 2011
ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM
K110963
Globus Medical, Inc.
Orthopedic · 29d
Cleared Apr 07, 2011
MOUNTAINEER OCT SPINAL SYSTEM
K110353
Depuy Spine, Inc.
Orthopedic · 59d
Cleared Apr 01, 2011
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K110522
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 37d
Cleared Jan 26, 2011
CD HORIZON SPINAL SYSTEM
K102886
Medtronic Sofamor Danek, Inc.
Orthopedic · 118d
Cleared Jan 19, 2011
SP-FIX SPINOUS PROCESS FIXATION PLATE
K102195
Globus Medical, Inc.
Orthopedic · 168d
Cleared Jan 13, 2011
CASPIAN SPINAL SYSTEM
K103232
K2m, Inc.
Orthopedic · 72d
Cleared Nov 09, 2010
MODIFICATION TO: OASYS SYSTEM
K101183
Stryker Spine
Orthopedic · 195d
Cleared Oct 22, 2010
PIONEER SPINOUS PROCESS FUSION PLATE
K101525
Pioneer Surgical Technology
Orthopedic · 142d
Cleared Oct 04, 2010
CASPIAN SPINAL SYSTEM
K101084
K2m, Inc.
Orthopedic · 168d
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 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 Aug 11, 2009
SENTINEL SPINAL SYSTEM
K090343
Life Spine
Orthopedic · 182d
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 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 Jan 16, 2009
VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K082728
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 120d