510(k) Report

Devices descending from K841189

2,425 later devices reach Oec/Rezaian Spinal Fixator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+5K133967Interbody Cage SystemAurora Spine2014227—
+5K133192Mectalif TipeekMedacta International201416—
+5K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+5K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+5K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+5K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+5K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+5K133207Staxx (R) SystemSpine Wave, Inc.20131—
+5K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+5K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+5K130853Idys (TM) CClariance20132—
+5K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+5K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+5K131178Idys Lif CagesClariance201311—
+5K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+5K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+5K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+5K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+5K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+5K121178Transcorp Acif SystemTranscorp, Inc.20130—
+5K131372Mobis IISignus Medizintechnik GmbH2013462—
+5K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+5K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+5K130699Aleutian Spinal SystemK2m, Inc.2013570—
+5K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+5K122877Range Spinal System, Small StatureK2m, Inc.201334—
+5K130445Vault Alif SystemSpinal USA20139—
+5K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+5K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+5K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+5K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+5K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+5K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+5K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+5K123134Easyspine SystemLdr Spine USA, Inc.20131—
+5K122592Instinct Java SystemZimmer Spine201301
+5K122097Patriot SpacersGlobus Medical, Inc.2012261—
+5K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+5K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+5K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+5K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+5K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+5K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+5K122896Cougar LS 15 Lateral Cage SystemMedos International SARL2012205—
+5K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+5K120401Alamo TAlliance Partners, LLC20121—
+5K121728Tiger Spine SystemCorelink, LLC201250—
+5K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+5K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+5K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+5K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+5K121630Range Spinal SystemK2m, Inc.2012127—
+5K120819Stalif CCentinel Spine, Inc.2012206—
+5K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+5K121172Reform Pedicle Screw SystemSpinal USA201233—
+5K120838Synthes Matrix SystemSynthes Spine201216—
+5K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+5K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+5K120564Calypso SystemHogan Lovells US LLP201216—
+5K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+5K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+5K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+5K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+5K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+5K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+5K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+5K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+5K120928Synthes Matrix SystemSynthes Spine20120—
+5K121116Plateau Spacer SystemLife Spine201213—
+5K121020Viper SystemDepuy Spine, Inc.201294—
+5K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+5K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+5K120656Everest Spinal SystemK2m, Inc.201243—
+5K120696Tiger Spine SystemCorelink, LLC201241—
+5K120576Zavation Ibf SystemZavation, LLC201232—
+5K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+5K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+5K113138Aleutian SystemK2m, Inc.2012549—
+5K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc.2011383—
+5K112664Zavation Ibf SystemsZavation, LLC201137—
+5K111123Varilift Cervical Interbody Fusion SystemWenzel Spine2011196—
+5K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+5K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+5K111484DiscoveryIntuitive Spine, LLC20111—
+5K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+5K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+5K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+5K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+5K100305Eturn Spinal Implant Model Eturn XX-12; Eturn XX-16 Where XX=07, 09, 11, 13, or 15 and…Icotec20118—
+5K111469Staxxsd SystemSpine Wave, Inc.20110—
+5K103382Intercontinental Plate-SpacerGlobus Medical, Inc.2011554—
+5K110177Helena SystemRoyal Oak Medical Devices20110—
+5K103729Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201122—
+5K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+5K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp.20110—
+5K103666Lanx LateralLanx, Inc.2011238—
+5K103743Concorde Curve SystemJohnson & Johnson20110—
+5K100698STCCCardinal Spine, LLC2011346—