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
Jul 29, 2015K143278LnK Posterior Cervical Fixation System
L&K BIOMED Co., Ltd., KR
KWP
Jun 9, 2015K150753OASYS System
Stryker Corporation
KWP
Jun 4, 2015K150851Sure Lok Mini Posterior Cervical/Upper Thoracic System
Precision Spine, Inc.
KWP
Apr 29, 2015K142867Reliance Posterior Cervical-Thoracic System
Reliance Medical Systems, LLC
KWP
Apr 28, 2015K150254Streamline OCT Occipito-Cervico-Thoracic System
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
KWP
Apr 23, 2015K142253SOLSTICE OCT System
Life Spine, Inc.
KWP
Apr 7, 2015K150229SOLSTICE OCT System
Life Spine, Inc.
KWP
Apr 7, 2015K143249SOLSTICE OCT System
Life Spine, Inc.
KWP
Jan 15, 2015K142741OASYS System
Stryker Corporation
KWP
Dec 22, 2014K142558Caspian OCT/MESA Mini/DENALI Mini Spinal System
K2m
KWP
Dec 15, 2014K140734NEXTGEN ALTIUS OCT SYSTEM
Ebi, LLC
KWP
Oct 1, 2014K142460EXPEDIUM Spine System/Synapse System
Johnson and Johnson
KWP
Sep 25, 2014K141897SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM
Synthes USA Products, LLC
KWP
Jul 23, 2014K141284CASPIAN SPINAL SYSTEM
K2m, Inc.
KWP
Jul 1, 2014K133288CASPIAN OCT SPINAL SYSTEM
K2m, Inc.
KWP
Jun 2, 2014K133556VIRAGE OCT SPINAL FIXATION SYSTEM
Zimmer Spine, Inc.
KWP
Apr 11, 2014K140645GIBRALT ROD-TO-ROD CROSS CONNECTORS
Exactech Sarasota
KWP
Mar 19, 2014K133374STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
Pioneer Surgical Technology, Inc. (Rti Surgical, I
KWP
Mar 7, 2014K133214BLACKBIRD SPINAL SYSTEM
Choicespine, LP
KWP
Jan 30, 2014K131833CENTURION POCT SYSTEM
Orthofix, Inc.
KWP
Jan 22, 2014K132122KESTREL POSTERIOR CERVICAL SPINE SYSTEM
Omni Surgical, LLC Dba Spine360
KWP
Jan 16, 2014K133698SYNAPSE SYSTEM
Synthes USA Products, LLC
KWP
Dec 11, 2013K133094CERTEX OCT SPINAL IMPLANT SYSTEM
X-Spine Systems, Inc.
KWP
Nov 25, 2013K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
Corelink, LLC
KWP
Oct 25, 2013K132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM
Intelligent Implant Systems, LLC
KWP
Oct 24, 2013K131427LOTUS
Spinal Elements, Inc.
KWP
Aug 22, 2013K132332MOUNTAINEER OCT SPINAL SYSTEM
Medos International SARL
KWP
May 24, 2013K131156LANX SPINAL FIXATION SYSTEM
Lanx, Inc.
KWP
Apr 1, 2013K123906VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM
Medtronic Sofamor Danek USA, Inc.
KWP
Mar 21, 2013K121979PASS OCT SPINAL SYSTEM
Medicrea International, FR
KWP
Mar 14, 2013K123783ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS
Globus Medical, Inc.
KWP
Feb 25, 2013K123656VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
Medtronic Sofamor Danek USA, Inc.
KWP
Feb 12, 2013K121877GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES
Exactech, Inc.
KWP
Feb 7, 2013K123232SPINEOLOGY SPINOUS PROCESS PLATE
Spineology, Inc.
KWP
Dec 20, 2012K123093STABILINK MIS SPINAL FIXATION SYSTEM
Southern Spine, LLC
KWP
Dec 18, 2012K123568VERTEX RECONSTRUCTION SYSTEM
Medtronic Sofamor Danek USA, Inc.
KWP
Dec 17, 2012K122509VERTIFLEX SPINOUS PROCESS FIXATION PLATE
Vertiflex, Inc.
KWP
Nov 7, 2012K121725PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
Pioneer Surgical Technology, Inc.
KWP
Oct 24, 2012K122292RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM
Reliance Medical Systems, LLC
KWP
Oct 1, 2012K120998SOLSTICE CROSS CONNECTOR
Life Spine
KWP
Sep 20, 2012K122378NEXTGEN ALTIUS OCT SYSTEM
Biomet Spine (Aka Ebi, LLC)
KWP
Aug 9, 2012K121136RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
Accel Spine
KWP
Jul 20, 2012K121808CASIAN, 3.5/4.5 CONNECTORS
K2m, Inc.
KWP
Jul 18, 2012K121115M.U.S.T PEDICLE SCREW SYSTEM
Medacta International
KWP
Jun 29, 2012K121191VERTEX RCCONSTRUCTION SYSTEM
Medtronic Sofamor Danek, Inc.
KWP
Apr 17, 2012K113593NEXTGEN ALTIUS OCT SYSTEM
Biomet Spine (Aka Ebi, LLC)
KWP
Mar 28, 2012K113324REXIOUS HOOK FIXATION SYSTEMS
Dio Medical Co., Ltd.
KWP
Mar 12, 2012K112757PIONEER POSTERIOR CERVICO THORACIC SYSTEM
Pioneer Surgical Technology, Inc.
KWP
Feb 28, 2012K113346NEON SYSTEM
Ulrich GmbH & Co. KG
KWP
Feb 13, 2012K112595COFLEX-F
Paradigm Spine, LLC
KWP

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