510(k) Report

Devices descending from K073669

508 later devices reach Oria Natura Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+1K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+1K133126K7 Lumbar SpacersK7, LLC20131—
+1K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC20136—
+1K111792Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSignus Medizintechnik GmbH2012470—
+2K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+2K172480icotec Interbody Cage SystemIcotec AG20185—
+2K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+2K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+2K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+2K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+2K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+2K123758Tasmin RSignus Medizintechnik GmbH20141—
+2K131372Mobis IISignus Medizintechnik GmbH2013462—
+2K122317Tetris IISignus Medizintechnik GmbH20122—
+3K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+3K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K192897icotec Cervical CageIcotec AG20201—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+3K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+3K172816TiGer Shark™ SystemChoicespine, LP201859—
+3K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+3K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+3K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+3K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+3K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+3K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+3K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+4K213417Ghost Spacer SystemLife Spine, Inc.20220—
+4K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+4K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+4K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+4K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+4K181829Velofix TLIF CageU&I Corporation20181—
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+4K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+4K150481Cascadia Interbody SystemK2m, Inc.20154593
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+5K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+5K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+5K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K223418DeGen Impulse AM™ SystemDegen Medical20236—
+5K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+5K222561AlignAcuity Surgical Devices, LLC202214—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K220610SOLO-LAurora Spine, Inc.20220—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K183243Velofix TLIF CageU&I Corporation20190—
+5K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+5K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+5K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+5K172941CASCADIA Interbody SystemK2m201852—
+5K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+5K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+5K170055CAPRI Corpectomy Cage SystemK2m201711—
+5K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+5K163364MOJAVE Expandable Interbody SystemK2m201725—
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+5K153621Juliet® TiSpineart2016751
+5K160125Cascadia Interbody SystemK2m2016315—
+5K160547Cascadia Interbody SystemK2m2016157—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K261049Scala® TLSpineart SA20260—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—