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 Feb 28, 2012
NEON SYSTEM
K113346
Ulrich GmbH & Co. KG
Orthopedic · 106d
Cleared Feb 13, 2012
COFLEX-F
K112595
Paradigm Spine, LLC
Orthopedic · 159d
Cleared Jan 19, 2012
OASYS SPINAL SYSTEM
K111719
Stryker Spine
Orthopedic · 213d
Cleared Jan 12, 2012
CASPIAN
K113654
K2m, Inc.
Orthopedic · 31d
Cleared Dec 05, 2011
AXLE PEEK INTERSPINOUS FUSION SYSTEM
K112592
X-Spine Systems, Inc.
Orthopedic · 89d
Cleared Sep 15, 2011
SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM
K112025
Spinal USA
Orthopedic · 62d
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 15, 2011
LANX SPINAL FIXATION SYSTEM
K103091
Lanx, Inc.
Orthopedic · 178d
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 Mar 23, 2011
PIONEER SPINAL PROCESS FUSION PLATE
K110367
Pioneer Surgical Technology, Inc.
Orthopedic · 43d
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 24, 2010
AXLE INTERSPINOUS FUSION SYSTEM
K101471
X-Spine Systems, Inc.
Orthopedic · 181d
Cleared Nov 15, 2010
MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
K100888
Lanx, Inc.
Orthopedic · 230d
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 Sep 01, 2010
VEGA SPAN SPINOUS PROCESS PLATE SYSTEM
K102020
Spinefrontier, Inc.
Orthopedic · 44d
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