510(k) Report

Devices descending from K072253

1,250 later devices reach Synfix-LR Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+6K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+6K211740DualXAmplify Surgical, Inc.20211—
+6K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+6K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K210728CONDUIT InstrumentsMedos International SARL20215—
+6K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+6K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+6K203444BEE HA CageNGMedical GmbH20211—
+6K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+6K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+6K193521Steerable Plateau TiLife Spine, Inc.20201—
+6K193258ProLift Expandable SystemLife Spine, Inc.20203—
+6K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+6K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+6K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K182608Oyster ACIF CageSilony Medical GmbH20190—
+6K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+6K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+6K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+6K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+6K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+6K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+6K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+6K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+6K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+6K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+6K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+6K181014Tritanium PL CageStryker Spine2018137—
+6K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+6K172568CervagePrecifit Medical, Ltd.20181—
+6K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K170235Lucent®Spinal Elements, Inc.2017107—
+6K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+6K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+6K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+6K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+6K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+6K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+6K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K161369EVEREST Spinal SystemK2m, Incorporated20169—
+6K160715AccuLIF TL and PL CageStryker Corporation20160—
+6K160547Cascadia Interbody SystemK2m2016157—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+6K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K151216Everest Spinal SystemK2m, Inc.201511—
+6K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+7K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+7K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+7K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+7K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+7K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—