510(k) Report

Devices descending from K973854

831 later devices reach Orion Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+9K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+9K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+9K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+9K241525ExcelsiusXR™Globus Medical, Inc.20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+9K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+9K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K243188Cylox® STSignus Medizintechnik GmbH20250—
+9K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+9K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+9K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+9K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+9K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+9K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+9K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+9K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+9K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+9K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+9K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+9K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+9K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+9K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+9K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+9K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+9K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+9K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+9K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+9K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K223326Axiom PSR SystemRestor3D202301
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K223418DeGen Impulse AM™ SystemDegen Medical20236—
+9K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+9K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+9K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+9K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+9K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+9K223251Hexanium PLIFSpinevision, S.A.S.20220—
+9K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+9K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+9K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+9K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+9K213417Ghost Spacer SystemLife Spine, Inc.20220—
+9K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+9K222561AlignAcuity Surgical Devices, LLC202214—
+9K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+9K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+9K220610SOLO-LAurora Spine, Inc.20220—
+9K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+9K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+9K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+9K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+9K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+9K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+9K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+9K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+9K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+9K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+9K203003Pantheon IBFDPantheon Spinal20210—
+9K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+9K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+9K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+9K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+9K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+9K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+9K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+9K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+9K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+9K202637F3D Corpectomy SystemCorelink, LLC20201—
+9K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+9K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+9K200316UNiD IB3D ALIFMedicrea International SA20200—