510(k) Report

Devices descending from K062083

1,252 later devices reach Synfix -LR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+5K202032Idys LLIF 3DTiClariance, Sas20210—
+5K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+5K210359Hexanium TLIFSpinevision, S.A.S.20211—
+5K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+5K202380Born PT-LIF Cage HASpineworxx AG20210—
+5K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+5K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+5K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+5K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+5K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+5K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+5K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+5K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+5K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+5K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+5K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+5K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+5K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+5K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+5K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+5K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+5K192897icotec Cervical CageIcotec AG20201—
+5K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+5K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+5K192993Scarlet AL-TSpineart20201—
+5K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+5K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+5K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+5K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+5K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+5K191134IB3D AlifMedicrea International SA20191—
+5K1803473d CageFims Co., Ltd.20190—
+5K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+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—
+5K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+5K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+5K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+5K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+5K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+5K183064TxTi IBF SystemInnovasis, Inc.2019481
+5K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+5K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+5K191263Idys ALIF TiVacClariance, Sas20190—
+5K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+5K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+5K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+5K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+5K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+5K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+5K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K182470Plateau Spacer SystemLife Spine20180—
+5K181829Velofix TLIF CageU&I Corporation20181—
+5K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+5K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+5K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+5K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+5K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+5K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+5K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+5K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+5K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+5K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+5K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+5K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+5K173128Alamo® CAlliance Partners, LLC20182—
+5K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+5K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+5K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+5K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+5K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—