510(k) Report

Devices descending from K003275

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K190284Bengal Stackable Cage SystemMedos International SARL20190—
+5K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+5K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+5K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+5K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+5K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K183407Triton CageMedyssey USA, Inc.20190—
+5K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+5K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+5K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+5K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+5K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+5K182470Plateau Spacer SystemLife Spine20180—
+5K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+5K181818Scarlet AL-TSpineart201864—
+5K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+5K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+5K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+5K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+5K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+5K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+5K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+5K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+5K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+5K173800Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy CageCamber Spine Technologies20180—
+5K172816TiGer Shark™ SystemChoicespine, LP201859—
+5K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+5K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+5K173148ACIFColigne AG20171—
+5K172424Velofix™ SA Cervical CageU&I Corporation201751
+5K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+5K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+5K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+5K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+5K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+5K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+5K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+5K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+5K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+5K162206Zavation IBFZavation, LLC201724—
+5K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+5K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+5K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+5K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+5K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+5K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+5K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+5K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+5K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+5K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+5K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+5K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+5K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+5K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+5K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+5K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+5K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+5K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+5K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+5K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+5K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+5K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+5K160291Optimus ALIF SystemAmendia, Inc.20160—
+5K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+5K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+5K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+5K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+5K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+5K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+5K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+5K150847Foundation Interbody DevicesCorelink, LLC201529—
+5K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+5K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+5K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+5K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+5K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+5K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+5K140348Interbody CageEisertech, LLC2015235—
+5K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+5K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+5K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+5K141798Sypher Spacer SystemBiogennix, LLC20151—
+5K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+5K142328nvcNvision Biomedical Technologies, LLC20144—
+5K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—