510(k) Report

Devices descending from K082848

74 later devices reach Nubic and Rabea Devices through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+1K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+1K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+1K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology201131—
+1K110915Cervical CageEisertech, LLC201123—
+2K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+2K1803473d CageFims Co., Ltd.20190—
+2K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+2K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+2K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+2K133784Vista-S Device, Associated InstrumentationZimmer Trabecular Metal Technology201429—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+2K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+2K122444Cervical CageEisertech, LLC201222—
+3K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+3K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+3K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K172424Velofix™ SA Cervical CageU&I Corporation201751
+3K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+3K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+4K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+4K242303MOD-COrthomod, LLC20260—
+4K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+4K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+4K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+4K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+4K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+4K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+4K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+4K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+4K183243Velofix TLIF CageU&I Corporation20190—
+4K181829Velofix TLIF CageU&I Corporation20181—
+4K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+4K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+5K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K201793EDEN Peek CageJmt Co., Ltd.20210—
+5K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+5K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+5K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+6K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—