510(k) Report

Devices descending from K973854

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+9K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+9K201087CORBEL SpacersGlobus Medical, Inc.202036—
+9K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+9K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+9K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+9K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+9K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+9K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+9K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+9K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+9K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+9K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+9K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+9K181397DualXInnovasive, Inc.201815—
+9K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+9K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+9K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+10K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+10K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+10K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K261279DeltaNEC Interbody SystemNexus Spine20260—
+10K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+10K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+10K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+10K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+10K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+10K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+10K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+10K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+10K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+10K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+10K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+10K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+10K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+10K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+10K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+10K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+10K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+10K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+10K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+10K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+10K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+10K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+10K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+10K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+10K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+10K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+10K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+10K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+10K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+10K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+10K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+10K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+10K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+10K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+10K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+10K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+10K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+10K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+10K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+10K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+10K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+10K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+10K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+10K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+10K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+10K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+10K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+10K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+10K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+10K211740DualXAmplify Surgical, Inc.20211—
+10K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+10K211306LabyrinthZavation Medical Products, LLC20213—
+10K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+10K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+10K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+10K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+10K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+10K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+10K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+10K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+10K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+10K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+10K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+10K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+10K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+10K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+11K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+11K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+11K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+11K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+11K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+11K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+11K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—