510(k) Report

Devices descending from K062759

1,406 later devices reach Paramount VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+7K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+7K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+7K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+7K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+7K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+7K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+7K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+7K212562Idys-C ZP 3DTiClariance, SA20211—
+7K211740DualXAmplify Surgical, Inc.20211—
+7K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+7K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+7K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+7K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+7K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+7K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+7K203444BEE HA CageNGMedical GmbH20211—
+7K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+7K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+7K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+7K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+7K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+7K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+7K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+7K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+7K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+7K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K193258ProLift Expandable SystemLife Spine, Inc.20203—
+7K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+7K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K190721LongBow TiLife Spine, Inc.20190—
+7K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+7K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+7K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+7K182608Oyster ACIF CageSilony Medical GmbH20190—
+7K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+7K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+7K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+7K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+7K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+7K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+7K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+7K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+7K180909REVEL SpacersGlobus Medical, Inc.201837—
+7K182584Lucent® XPSpinal Elements, Inc.20183—
+7K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+7K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+7K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+7K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+7K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+7K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+7K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+7K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+7K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+7K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+7K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+7K172065Scarlet AC-TSpineart20172—
+7K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+7K171519FLXfit™Expanding Orthopedics, Inc.2017711
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+7K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+7K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+7K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+7K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+7K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+7K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—