510(k) Report

Devices descending from K072791

1,055 later devices reach Oracle Spacer, Opal Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+1K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+1K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+1K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+1K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+1K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+1K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+1K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+1K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+1K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+1K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+1K140303Alamo TAlliance Partners, LLC20140—
+1K131178Idys Lif CagesClariance201311—
+1K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+1K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+1K131671MectalifMedacta International201322—
+1K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+1K123180Falcon SpacerSynthes (USA) Products, LLC2013147—
+1K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+1K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+1K113478Plif CageEisertech, LLC2012269—
+1K120024Mectalif TransforaminalMedacta International S.A.201223—
+1K112664Zavation Ibf SystemsZavation, LLC201137—
+1K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+1K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+1K110927MectalifMedacta International2011301
+1K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+1K092815S-Lif Intervertebral Body Fusion DeviceSpinefrontier, Inc.2010156
+1K081177Blackstone Medical, Inc., Pillar Spacer SystemBlackstone Medical, Inc.2008848—
+2K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+2K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+2K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+2K251016MectaLIF 3D MetalMedacta International S.A.20250—
+2K243670Idys® LIFClariance20240—
+2K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+2K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+2K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+2K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+2K212831MectaLIF ExtensionMedacta International S.A.20211—
+2K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+2K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+2K202032Idys LLIF 3DTiClariance, Sas20210—
+2K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+2K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+2K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+2K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+2K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+2K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K183092Kuros TLIF CageKuros Biosciences B.V20190—
+2K183259Idys™ TLIF TiVacClariance, Sas20191—
+2K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+2K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+2K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+2K181899Roccia® PlifSilony Medical GmbH20180—
+2K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+2K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+2K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+2K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+2K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+2K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+2K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+2K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+2K172083Idys™ ALIF SystemClariance, Sas20177—
+2K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+2K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+2K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+2K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+2K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+2K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+2K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+2K150847Foundation Interbody DevicesCorelink, LLC201529—
+2K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+2K140348Interbody CageEisertech, LLC2015235—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+2K140280ForticoreNanovis, LLC20149—
+2K132738Cogent Med-LifCogent Spine, LLC201413—
+2K133967Interbody Cage SystemAurora Spine2014227—
+2K133192Mectalif TipeekMedacta International201416—
+2K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+2K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+2K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+2K124034Mectalif AnteriorMedacta International201311—
+2K122021Sterispine LC CageSafe Orthopaedics20122—
+2K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+2K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+2K120576Zavation Ibf SystemZavation, LLC201232—
+2K112862Mecta-CMedacta International201114—
+2K111553Spinefrontier Lumbar Ibf SystemSpinefrontier, Inc.201114—
+2K111569Plateau Spacer SystemLife Spine2011181—
+2K103111Forza Spacer SystemOrthofix, Inc.20113431
+2K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531