510(k) Report

Devices descending from K073351

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+4K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+4K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K190284Bengal Stackable Cage SystemMedos International SARL20190—
+4K191134IB3D AlifMedicrea International SA20191—
+4K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K190885Elevation Spine Saber-C SystemElevation Spine201925—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K190680Favo S-TlifSilony Medical GmbH20190—
+4K183243Velofix TLIF CageU&I Corporation20190—
+4K182608Oyster ACIF CageSilony Medical GmbH20190—
+4K190380nvcNvision Biomedical Technologies, Inc.20193—
+4K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+4K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+4K183259Idys™ TLIF TiVacClariance, Sas20191—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+4K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+4K180909REVEL SpacersGlobus Medical, Inc.201837—
+4K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+4K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+4K181829Velofix TLIF CageU&I Corporation20181—
+4K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+4K181397DualXInnovasive, Inc.201815—
+4K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+4K181337Sypher Spacer SystemBiogennix, LLC20180—
+4K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+4K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+4K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+4K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+4K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+4K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+4K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K173128Alamo® CAlliance Partners, LLC20182—
+4K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+4K172941CASCADIA Interbody SystemK2m201852—
+4K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+4K170235Lucent®Spinal Elements, Inc.2017107—
+4K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+4K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+4K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+4K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+4K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+4K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+4K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+4K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+4K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+4K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+4K162587Roccia® AcifSilony Medical GmbH20171—
+4K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+4K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+4K162264Cascadia Interbody SystemK2m, Inc.2016169—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+4K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+4K153621Juliet® TiSpineart2016751
+4K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+4K160547Cascadia Interbody SystemK2m2016157—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+4K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+4K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—