510(k) Report

Devices descending from K042499

694 later devices reach Orion Anterior Cervical Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+8K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K222561AlignAcuity Surgical Devices, LLC202214—
+8K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+8K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+8K220610SOLO-LAurora Spine, Inc.20220—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+8K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+8K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+8K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+8K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+8K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+8K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+8K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+8K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+8K203003Pantheon IBFDPantheon Spinal20210—
+8K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+8K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+8K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+8K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+8K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+8K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+8K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+8K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+8K202637F3D Corpectomy SystemCorelink, LLC20201—
+8K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+8K200316UNiD IB3D ALIFMedicrea International SA20200—
+8K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+8K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+8K201087CORBEL SpacersGlobus Medical, Inc.202036—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+8K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+8K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+8K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+8K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+8K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+8K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+8K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+8K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+8K181397DualXInnovasive, Inc.201815—
+8K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+8K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+8K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+9K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+9K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+9K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+9K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+9K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+9K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+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—
+9K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+9K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+9K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+9K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+9K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+9K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+9K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+9K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+9K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+9K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+9K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+9K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+9K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+9K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+9K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+9K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—