510(k) Report

Devices descending from K081888

282 later devices reach Dynamik Intervertebral Body Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172020Arlington PLIF/TLIF CageSignature Orthopaedics Pty, Ltd.20170—
+1K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+1K153621Juliet® TiSpineart2016751
+1K141135Juliet LLSpineart2014146—
+1K142277Juliet POSpineart2014119—
+1K140474Juliet OLSpineart2014120—
+1K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+1K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+1K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+1K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+1K120024Mectalif TransforaminalMedacta International S.A.201223—
+1K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+1K101720Juliet OLSpineart2010259—
+2K261049Scala® TLSpineart SA20260—
+2K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+2K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K200312Tryptik TiSpineart20202—
+2K191796Neo Cage SystemNeo Medical SA20190—
+2K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+2K181048Neo Cage System TMNeo Medical SA20191—
+2K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+2K181963ostaPek Interbody Fusion CagesColigne AG20181—
+2K181818Scarlet AL-TSpineart201864—
+2K181203Juliet TiSpineart20181—
+2K172816TiGer Shark™ SystemChoicespine, LP201859—
+2K173702Juliet Ti LLSpineart20182—
+2K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+2K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+2K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+2K131671MectalifMedacta International201322—
+2K112696Twin Peaks Lumbar CageQualgenix, LLC20120—
+3K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+3K251016MectaLIF 3D MetalMedacta International S.A.20250—
+3K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+3K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+3K242589Scarlet® AL-TSpineart SA20240—
+3K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+3K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+3K230583Tryptik TiSpineart SA20231—
+3K213417Ghost Spacer SystemLife Spine, Inc.20220—
+3K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+3K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+3K212831MectaLIF ExtensionMedacta International S.A.20211—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+3K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K192993Scarlet AL-TSpineart20201—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+3K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+3K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+3K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+3K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+3K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+3K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+3K163180Hubble IIOrbbo Surgical, LLC20160—
+3K133192Mectalif TipeekMedacta International201416—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+4K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+4K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+4K223418DeGen Impulse AM™ SystemDegen Medical20236—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+4K222561AlignAcuity Surgical Devices, LLC202214—
+4K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+4K220610SOLO-LAurora Spine, Inc.20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K201793EDEN Peek CageJmt Co., Ltd.20210—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+4K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+4K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+4K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+4K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+4K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+4K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—