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
+6K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+6K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+6K223326Axiom PSR SystemRestor3D202301
+6K230026SqualeImplanet, S.A.20230—
+6K230583Tryptik TiSpineart SA20231—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+6K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+6K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+6K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+6K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+6K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+6K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+6K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+6K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+6K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+6K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+6K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+6K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+6K200919Idys ALIF 3DTiClariance20210—
+6K202032Idys LLIF 3DTiClariance, Sas20210—
+6K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+6K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+6K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+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—
+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—
+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—
+6K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+6K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+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—
+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
+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—
+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—
+6K171425Concorde LiftMedos International SARL201782
+6K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+6K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+6K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—