510(k) Report

Devices descending from K040928

1,504 later devices reach Expandable Peek VBR Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+8K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+8K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+8K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+8K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+8K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+8K201087CORBEL SpacersGlobus Medical, Inc.202036—
+8K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+8K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+8K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+8K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+8K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+8K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+8K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+8K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+8K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+8K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+8K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+8K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+8K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+8K190488ProLift Expandable SystemLife Spine, Inc.201916—
+8K190680Favo S-TlifSilony Medical GmbH20190—
+8K182608Oyster ACIF CageSilony Medical GmbH20190—
+8K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+8K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+8K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+8K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+8K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+8K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+8K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+8K181963ostaPek Interbody Fusion CagesColigne AG20181—
+8K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+8K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+8K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+8K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+8K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+8K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+8K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+8K173128Alamo® CAlliance Partners, LLC20182—
+8K172115Navigated Instrument SystemOrthofix, Inc.20184—
+8K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+8K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+8K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+8K173508Everest Spinal SystemK2m20189—
+8K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+8K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+8K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+8K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+8K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+8K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+8K162496Foundation 3D InterbodyCorelink, LLC201782—
+8K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+8K162921Navigated Instrument SystemOrthofix, Inc.20175—
+8K163180Hubble IIOrbbo Surgical, LLC20160—
+8K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+8K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+8K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+8K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+8K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+8K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+8K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+8K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+8K153400ProLift Expandable SystemLife Spine, Inc.201672—
+8K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+8K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+8K152651AccuLIF TL and PL CageStryker Corporation201530—
+8K152304Tritanium PL CageStryker20154481
+8K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+8K143479Bluefin Interbody SystemTides Medical20152—
+8K151727Everest Spinal SystemK2m, Inc.201511—
+8K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+8K142360Everest Spinal SystemK2m, Inc.201522—
+8K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+8K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+8K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+8K133717Longbow Spacer SystemLife Spine20149—
+8K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+8K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+8K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+8K141147Range Spinal SystemK2m, Inc.20141—
+8K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+8K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+8K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+8K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+8K130194Acculif XL CageCoalign Innovations, Inc.20131—
+8K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+8K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+8K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K261430TruLift Expandable SystemLife Spine, Inc.20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+9K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+9K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+9K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—