510(k) Report

Devices descending from K003836

1,330 later devices reach Synthes Synex Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K171519FLXfit™Expanding Orthopedics, Inc.2017711
+4K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+4K171704CAPRI Corpectomy Cage SystemK2m201710—
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+4K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+4K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+4K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K162206Zavation IBFZavation, LLC201724—
+4K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+4K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+4K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura…SeaSpine Orthopedics Corporation2016103—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+4K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+4K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+4K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+4K153413PASS LP Spinal SystemMedicrea International SA20160—
+4K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+4K160291Optimus ALIF SystemAmendia, Inc.20160—
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+4K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+4K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+4K150847Foundation Interbody DevicesCorelink, LLC201529—
+4K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+4K141798Sypher Spacer SystemBiogennix, LLC20151—
+4K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+4K142328nvcNvision Biomedical Technologies, LLC20144—
+4K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+4K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+4K141942Midline II TICentinel Spine, Inc.2014459—
+4K142016CAPRIK2m, Inc.201412—
+4K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+4K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+4K141337Arena-CSpinefrontier, Inc.20141—
+4K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+4K141005Z-Link CervicalZavation, LLC20144—
+4K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+4K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+4K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+4K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+4K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+4K133286Midline (TM)Centinel Spine, Inc.2014460—
+4K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+4K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+4K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+4K133126K7 Lumbar SpacersK7, LLC20131—
+4K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+4K130254Prow FusionNlt Spine, Ltd.20138—
+4K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+4K130461Stalif XCentinel Spine, Inc.201313—
+4K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+4K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013593—
+4K121178Transcorp Acif SystemTranscorp, Inc.20130—
+4K131372Mobis IISignus Medizintechnik GmbH2013462—
+4K122588Vusion CS PlusOrtho Development Corp.2013206—
+4K124034Mectalif AnteriorMedacta International201311—
+4K123913Latis SpacerGlobus Medical, Inc.201388—
+4K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+4K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+4K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+4K120401Alamo TAlliance Partners, LLC20121—
+4K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+4K121176STGCCardinal Spine, LLC201259—
+4K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+4K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+4K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+4K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+4K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+4K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+4K120656Everest Spinal SystemK2m, Inc.201243—
+4K120576Zavation Ibf SystemZavation, LLC201232—
+4K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+4K120024Mectalif TransforaminalMedacta International S.A.201223—
+4K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+4K113138Aleutian SystemK2m, Inc.2012549—
+4K113559LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc.2011383—
+4K112664Zavation Ibf SystemsZavation, LLC201137—
+4K111123Varilift Cervical Interbody Fusion SystemWenzel Spine2011196—
+4K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+4K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+4K111484DiscoveryIntuitive Spine, LLC20111—
+4K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+4K110177Helena SystemRoyal Oak Medical Devices20110—