510(k) Report

Devices descending from K003275

1,705 later devices reach Synthes Synmesh Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+5K141942Midline II TICentinel Spine, Inc.2014459—
+5K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+5K133717Longbow Spacer SystemLife Spine20149—
+5K141337Arena-CSpinefrontier, Inc.20141—
+5K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+5K141005Z-Link CervicalZavation, LLC20144—
+5K133815Intess Cervical Cage SystemKalitec Direct, LLC20144—
+5K140003Coroent Small Interbody SystemNuvasive, Inc.2014453—
+5K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+5K133286Midline (TM)Centinel Spine, Inc.2014460—
+5K131880Spinefrontier a-Cift Solofuse Cervical Intervertebral Fusion Device SystemSpinefrontier, Inc.201427—
+5K131724Pioneer Maxfuse Vertebral Body Replacement DevicePioneer Surgical Technology, Inc.201373—
+5K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+5K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+5K133126K7 Lumbar SpacersK7, LLC20131—
+5K133207Staxx (R) SystemSpine Wave, Inc.20131—
+5K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+5K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+5K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+5K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+5K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+5K121178Transcorp Acif SystemTranscorp, Inc.20130—
+5K131372Mobis IISignus Medizintechnik GmbH2013462—
+5K122588Vusion CS PlusOrtho Development Corp.2013206—
+5K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+5K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+5K123969XiphosDifusion Technologies201314—
+5K123134Easyspine SystemLdr Spine USA, Inc.20131—
+5K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+5K122008Incite Anchored Cervical Interbody (Aci) Fusion DeviceIncite Innovation, LLC201210—
+5K120401Alamo TAlliance Partners, LLC20121—
+5K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+5K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+5K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+5K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+5K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+5K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+5K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+5K121116Plateau Spacer SystemLife Spine201213—
+5K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+5K120656Everest Spinal SystemK2m, Inc.201243—
+5K120576Zavation Ibf SystemZavation, LLC201232—
+5K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+5K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+5K120024Mectalif TransforaminalMedacta International S.A.201223—
+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
+5K110843Aleutian Spacer SystemK2m, Inc.2011589—
+5K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+5K110177Helena SystemRoyal Oak Medical Devices20110—
+5K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+5K103666Lanx LateralLanx, Inc.2011238—
+5K100698STCCCardinal Spine, LLC2011346—
+5K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+5K102738Lanx Fusion SystemLanx, LLC20113281
+5K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+5K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+5K102067Endoskeleton toTitan Spine, LLC2010337—
+5K101288Staxx XD SystemSpine Wave, Inc.201051
+5K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+5K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+5K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+5K082698Aleutian Ibf SystemK2m, Inc.2009662—
+5K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+5K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+5K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+5K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+5K063399Aleutian Spacer SystemK2m, Inc.2007663—
+5K052210Nuvasive Coroent Extensure SystemNuvasive, Inc.2005263—
+6K263049SABER-C SystemElevation Spine20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+6K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—