510(k) Report

Devices descending from K073351

1,154 later devices reach Crystal through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K212831MectaLIF ExtensionMedacta International S.A.20211—
+3K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K211413BEE PLIF CageNGMedical GmbH20211—
+3K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K200429BEE CagesNGMedical GmbH202111—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+3K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+3K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+3K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K192897icotec Cervical CageIcotec AG20201—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K1803473d CageFims Co., Ltd.20190—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+3K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+3K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+3K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+3K182584Lucent® XPSpinal Elements, Inc.20183—
+3K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+3K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+3K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+3K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+3K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+3K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+3K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+3K172568CervagePrecifit Medical, Ltd.20181—
+3K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+3K171312FortiCore®Nanovis, LLC20183—
+3K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+3K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+3K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+3K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+3K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+3K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+3K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+3K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+3K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+3K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+3K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+3K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+3K163265Kepler IIOrbbo Surgical, LLC20170—
+3K162206Zavation IBFZavation, LLC201724—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+3K162694Ayers Rock Cervical interbody fusion systemSpineway20170—
+3K162531Sterispine CCSafe Orthopaedics20160—
+3K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+3K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+3K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+3K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+3K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K152622Alta ACDF SystemBiomet Spine20160—