510(k) Report

Devices descending from K073202

644 later devices reach Ardis Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1905634CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage…Solco Biomedical Co., Ltd.20192—
+1K133184Ardis Interbody SystemZimmer Spine, Inc.201420—
+1K132790Infix Anterior Lumbar SystemZimmer Spine, Inc.201328—
+1K131242Ardis Interbody SystemZimmer Spine, Inc.20130—
+1K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+1K113561TM Ardis Interbody System TM Ardis Interbody System InstrumenationZimmer Trabecular Metal Technology20124762
+1K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+1K111965Vusion (R) OSOrtho Development20110—
+1K103111Forza Spacer SystemOrthofix, Inc.20113431
+1K080588Scient'x Tribeca VBRScient'X USA, Inc.2008250—
+1K073502Vertebron VBR SystemVertebron, Inc.200812—
+2K243973FIX-L PEEK PLIF and T-PLIF SystemJeil Medical Corporation20250—
+2K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+2K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+2K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+2K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+2K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+2K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+2K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+2K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+2K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+2K180695FBC 921 (Alif)Fbc Device Aps20180—
+2K172480icotec Interbody Cage SystemIcotec AG20185—
+2K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+2K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+2K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+2K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+2K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+2K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+2K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+2K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+2K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+2K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K150481Cascadia Interbody SystemK2m, Inc.20154593
+2K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+2K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+2K140280ForticoreNanovis, LLC20149—
+2K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+2K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+2K123602TM Ardis Interbody System InserterZimmer Trabecular Metal Technology20131—
+2K112801Ayers Rock Cervical CageQualgenix20122—
+2K112696Twin Peaks Lumbar CageQualgenix, LLC20120—
+2K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+3K2530413d Cage CervicalFims Co., Ltd.20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K261067BEE PLIF CageNGMedical GmbH20260—
+3K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K241073DZ-Tabone Intervertebral Body Fusion DeviceShenzhen Dazhou Medical Technology Co., Ltd.20240—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+3K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+3K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+3K211413BEE PLIF CageNGMedical GmbH20211—
+3K200429BEE CagesNGMedical GmbH202111—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+3K200312Tryptik TiSpineart20202—
+3K192897icotec Cervical CageIcotec AG20201—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K1803473d CageFims Co., Ltd.20190—
+3K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+3K183407Triton CageMedyssey USA, Inc.20190—
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+3K172941CASCADIA Interbody SystemK2m201852—
+3K171312FortiCore®Nanovis, LLC20183—
+3K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+3K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+3K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+3K172424Velofix™ SA Cervical CageU&I Corporation201751
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+3K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+3K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—