510(k) Report

Devices descending from K062083

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+7K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+7K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+7K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+7K211740DualXAmplify Surgical, Inc.20211—
+7K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K203444BEE HA CageNGMedical GmbH20211—
+7K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+7K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K193521Steerable Plateau TiLife Spine, Inc.20201—
+7K193258ProLift Expandable SystemLife Spine, Inc.20203—
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+7K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+7K182608Oyster ACIF CageSilony Medical GmbH20190—
+7K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+7K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+7K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+7K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+7K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+7K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+7K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+7K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+7K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+7K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+7K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+7K181014Tritanium PL CageStryker Spine2018137—
+7K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K172568CervagePrecifit Medical, Ltd.20181—
+7K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+7K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+7K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+7K170235Lucent®Spinal Elements, Inc.2017107—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+7K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+7K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+7K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+7K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+7K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+7K160715AccuLIF TL and PL CageStryker Corporation20160—
+7K160547Cascadia Interbody SystemK2m2016157—
+7K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+7K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K133402K2M Modular HooksK2m, Inc.20140—
+7K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+8K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+8K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+8K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+8K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—