ClearanceBrief
Panels › Orthopedic › Product code KWP · Class 2

Appliance, Fixation, Spinal Interlaminal

Regulation 888.3050

0510(k)s in 12 months (430 all time)
0recalls in 12 months (68 all time)
65recalls that name a 510(k)
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Top companies in KWP

Company510(k)sRecalls
Medtronic Sofamor Danek5412
Synthes (Usa)170
Zimmer, Inc.710
Danek Medical, Inc.160
K2m123
Acromed Corp.140
Seaspine, Inc.310
Sofamor Danek USA,Inc.130
Depuy, Inc.110
Alphatec Spine, Inc.46
Decided510(k)Device and applicantCode
Jan 19, 2012K111719OASYS SPINAL SYSTEM
Stryker Spine
KWP
Jan 12, 2012K113654CASPIAN
K2m, Inc.
KWP
Dec 5, 2011K112592AXLE PEEK INTERSPINOUS FUSION SYSTEM
X-Spine Systems, Inc.
KWP
Sep 15, 2011K112025SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM
Spinal USA
KWP
Jun 2, 2011K103205BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM
Alphatec Spine, Inc.
KWP
May 24, 2011K111183ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS)
Orthofix, Inc.
KWP
May 5, 2011K110963ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM
Globus Medical, Inc.
KWP
Apr 15, 2011K103091LANX SPINAL FIXATION SYSTEM
Lanx, Inc.
KWP
Apr 7, 2011K110353MOUNTAINEER OCT SPINAL SYSTEM
Depuy Spine, Inc.
KWP
Apr 1, 2011K110522VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
Medtronic Sofamor Danek USA, Inc.
KWP
Mar 23, 2011K110367PIONEER SPINAL PROCESS FUSION PLATE
Pioneer Surgical Technology, Inc.
KWP
Jan 26, 2011K102886CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek, Inc.
KWP
Jan 19, 2011K102195SP-FIX SPINOUS PROCESS FIXATION PLATE
Globus Medical, Inc.
KWP
Jan 13, 2011K103232CASPIAN SPINAL SYSTEM
K2m, Inc.
KWP
Nov 24, 2010K101471AXLE INTERSPINOUS FUSION SYSTEM
X-Spine Systems, Inc.
KWP
Nov 15, 2010K100888MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
Lanx, Inc.
KWP
Nov 9, 2010K101183MODIFICATION TO: OASYS SYSTEM
Stryker Spine
KWP
Nov 4, 2010K101112RELIANCE SPINAL SCREW SYSTEM
Reliance Medical Systems
KWP
Oct 22, 2010K101525PIONEER SPINOUS PROCESS FUSION PLATE
Pioneer Surgical Technology
KWP
Oct 6, 2010K093438PARADIGM INTERSPINOUS FUSION PLATE
Paradigm Spine, LLC
KWP
Oct 4, 2010K101084CASPIAN SPINAL SYSTEM
K2m, Inc.
KWP
Sep 1, 2010K102020VEGA SPAN SPINOUS PROCESS PLATE SYSTEM
Spinefrontier, Inc.
KWP
Aug 17, 2010K100354PRIMAL OK INTERSPINOUS FUSION SYSTEM
Osteomed LP
KWP
Jun 23, 2010K093319NUVASIVE VUEPOINT OCT SYSTEM
Nuvasive, Inc.
KWP
Jun 18, 2010K100685ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
Alphatec Spine, Inc.
KWP
Apr 15, 2010K100191LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
Lanx, Inc.
KWP
Mar 16, 2010K092825APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER
Spinecraft, Inc.
KWP
Feb 19, 2010K092295PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
Pioneer Surgical Technology
KWP
Dec 16, 2009K093534MODIFICATION TO CASPIAN SPINAL SYSTEM
K2m, Inc.
KWP
Nov 24, 2009K092656LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
Lanx, Inc.
KWP
Sep 2, 2009K091359GSO PCT SPINAL SYSTEM
Gold Standard Orthopaedics, LLC
KWP
Aug 11, 2009K090343SENTINEL SPINAL SYSTEM
Life Spine
KWP
Aug 6, 2009K091365VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
Medtronic Soafamor Danek
KWP
Jul 10, 2009K091689SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
Synthes (Usa)
KWP
Jun 30, 2009K090565ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM
Globus Medical, Inc.
KWP
Jun 2, 2009K090060NEXLINK OCT SYSTEM, MODEL 7000 SERIES
Abbott Spine, Inc.
KWP
May 21, 2009K090549SYNTHES SYNAPSE TRANSCONNECTOR
Synthes Spine
KWP
Apr 17, 2009K090714VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
Medtronic Sofamor Danek
KWP
Mar 4, 2009K090252MODIFICATION TO: LANX SPINAL FIXATION SYSTEM
Lanx, Inc.
KWP
Jan 16, 2009K082728VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
Medtronic Sofamor Danek USA, Inc.
KWP
Dec 11, 2008K082769MESA AND RANGE SPINAL SYSTEMS
K2m, Inc.
KWP
Nov 14, 2008K083071VERTEX RECONSTRUCTION SYSTEM
Medtronic Sofamor Danek
KWP
Nov 14, 2008K081906PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
Globus Medical, Inc.
KWP
Oct 10, 2008K081107CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS
K2m, Inc.
KWP
Jun 11, 2008K081297VERTEX RECONSTRUCTION SYSTEM
Medtronic Sofamor Danek
KWP
Apr 29, 2008K080790MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM
Theken Spine, LLC
KWP
Apr 18, 2008K080805MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
Medtronic Sofamor Danek
KWP
Apr 17, 2008K072729SIERRA
Seaspine, Inc.
KWP
Apr 16, 2008K080526SIERRA SYSTEM
Seaspine, Inc.
KWP
Mar 28, 2008K073278SPINOUS PROCESS PLATE SYSTEM
Nuvasive, Inc.
KWP

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