510(k) Report

Devices descending from K080758

1,091 later devices reach Avs PL Peek Spacers, Models 48351 and 48353 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+6K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+6K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+6K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+6K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+6K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+6K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+6K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+6K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+6K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+6K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+6K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+6K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+6K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K191134IB3D AlifMedicrea International SA20191—
+6K1803473d CageFims Co., Ltd.20190—
+6K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+6K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+6K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+6K190680Favo S-TlifSilony Medical GmbH20190—
+6K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+6K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+6K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+6K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+6K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+6K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+6K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+6K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+6K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K182584Lucent® XPSpinal Elements, Inc.20183—
+6K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+6K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+6K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+6K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+6K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+6K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+6K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+6K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+6K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+6K172568CervagePrecifit Medical, Ltd.20181—
+6K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+6K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+6K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+6K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+6K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+6K172941CASCADIA Interbody SystemK2m201852—
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+6K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+6K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+6K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+6K172065Scarlet AC-TSpineart20172—
+6K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+6K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+6K171704CAPRI Corpectomy Cage SystemK2m201710—
+6K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+6K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+6K171425Concorde LiftMedos International SARL201782
+6K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+6K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+6K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+6K161129Pillar SA PTCOrthofix, Inc.201619—
+6K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+6K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+6K160547Cascadia Interbody SystemK2m2016157—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+6K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+6K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+6K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+6K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+6K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+6K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+6K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+6K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+6K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+6K132738Cogent Med-LifCogent Spine, LLC201413—
+6K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+6K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+7K263049SABER-C SystemElevation Spine20260—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K261279DeltaNEC Interbody SystemNexus Spine20260—