510(k) Report

Devices descending from K062759

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+6K173508Everest Spinal SystemK2m20189—
+6K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+6K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+6K170235Lucent®Spinal Elements, Inc.2017107—
+6K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+6K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+6K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+6K171704CAPRI Corpectomy Cage SystemK2m201710—
+6K171140Matrixx SystemNexxt Spine, LLC2017145—
+6K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+6K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+6K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+6K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+6K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+6K162496Foundation 3D InterbodyCorelink, LLC201782—
+6K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+6K162921Navigated Instrument SystemOrthofix, Inc.20175—
+6K163180Hubble IIOrbbo Surgical, LLC20160—
+6K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+6K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+6K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+6K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+6K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+6K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+6K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+6K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+6K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+6K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+6K153400ProLift Expandable SystemLife Spine, Inc.201672—
+6K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+6K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+6K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+6K152651AccuLIF TL and PL CageStryker Corporation201530—
+6K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+6K152304Tritanium PL CageStryker20154481
+6K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+6K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+6K143479Bluefin Interbody SystemTides Medical20152—
+6K151727Everest Spinal SystemK2m, Inc.201511—
+6K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+6K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+6K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+6K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+6K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+6K133717Longbow Spacer SystemLife Spine20149—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+6K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+6K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+6K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+6K141147Range Spinal SystemK2m, Inc.20141—
+6K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+6K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+6K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+6K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+6K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+6K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+6K130194Acculif XL CageCoalign Innovations, Inc.20131—
+6K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+6K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+6K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K261430TruLift Expandable SystemLife Spine, Inc.20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+7K253260ORIO-3D Cage SystemSpineCraft20260—
+7K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+7K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+7K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+7K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+7K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+7K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—