510(k) Report

Devices descending from K073470

1,102 later devices reach Avs PL Peek Spacers, Models 48351XXX and 48353XXX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K210359Hexanium TLIFSpinevision, S.A.S.20211—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+3K192897icotec Cervical CageIcotec AG20201—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+3K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+3K1803473d CageFims Co., Ltd.20190—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+3K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+3K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K181963ostaPek Interbody Fusion CagesColigne AG20181—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+3K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+3K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+3K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+3K163180Hubble IIOrbbo Surgical, LLC20160—
+3K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+3K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+3K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+3K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K152304Tritanium PL CageStryker20154481
+3K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+3K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+3K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+3K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+3K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+3K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+3K143616AccuLIF TL and PL CageStryker Corporation20154694
+3K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+3K141135Juliet LLSpineart2014146—
+3K142277Juliet POSpineart2014119—
+3K133717Longbow Spacer SystemLife Spine20149—
+3K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+3K140280ForticoreNanovis, LLC20149—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+3K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+3K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+3K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+3K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+3K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+3K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+3K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+3K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+3K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+3K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+3K100743Atlas Spine Pivoting SystemAtlas Spine, Inc.20104—
+3K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+3K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+3K092574Esl Spinal SystemEbi, L.P.2010181—
+3K092336C-Thru Spinal SystemEbi, L.P.2009492—
+3K091381Ibex Spinal SystemEbi, L.P.2009181—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261049Scala® TLSpineart SA20260—