510(k) Report

Devices descending from K083626

660 later devices reach Distractable Wave Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212050NGM WAVE PLIF CageNGMedical GmbH20210—
+1K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+1K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+1K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+1K141980Leva (TM) Spacer SystemSpine Wave, Inc.20159—
+1K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+1K121330Wave O CageAdvanced Medical Technologies AG20121—
+1K1123164-Web Alif Spinal Truss System (STS)4-Web, Inc.20115371
+1K103111Forza Spacer SystemOrthofix, Inc.20113431
+2K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+2K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+2K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+2K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+2K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+2K180695FBC 921 (Alif)Fbc Device Aps20180—
+2K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+2K170341Medussa-PL CageMedyssey USA, Inc.20174—
+2K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+2K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+2K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+2K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+2K163246Leva Anterior Expandable Spacer SystemSpine Wave, Inc.20170—
+2K153436LATERAL Spine Truss System4Web, Inc.20165—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+2K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K150481Cascadia Interbody SystemK2m, Inc.20154593
+2K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+2K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+2K151581Leva Spacer SystemSpine Wave, Inc.20156—
+2K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+2K150285Leva (TM) Spacer SystemSpine Wave, Inc.20157—
+2K1421124WEB Spinal Implant Products4Web, Inc.201433—
+2K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+2K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+2K133207Staxx (R) SystemSpine Wave, Inc.20131—
+2K131071Staxx Ibl SystemSpine Wave, Inc.20138—
+2K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+3K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+3K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K223654Medussa-PL CageMedyssey USA, Inc.20220—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K200283Medussa-PL CageMedyssey USA, Inc.20200—
+3K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K191134IB3D AlifMedicrea International SA20191—
+3K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+3K183407Triton CageMedyssey USA, Inc.20190—
+3K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+3K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+3K172941CASCADIA Interbody SystemK2m201852—
+3K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+3K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+3K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+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—
+3K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K163364MOJAVE Expandable Interbody SystemK2m201725—
+3K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+3K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+3K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+3K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+3K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+3K162264Cascadia Interbody SystemK2m, Inc.2016169—
+3K161129Pillar SA PTCOrthofix, Inc.201619—
+3K153621Juliet® TiSpineart2016751
+3K160125Cascadia Interbody SystemK2m2016315—
+3K153222Leva Spacer SystemSpine Wave, Inc.20165—
+3K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+3K160547Cascadia Interbody SystemK2m2016157—