510(k) Report

Devices descending from K042235

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+9K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+9K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+9K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+9K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+9K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+9K211740DualXAmplify Surgical, Inc.20211—
+9K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+9K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+9K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+9K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+9K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+9K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+9K201287Impulse Interbody Fusion SystemDegen Medical20208—
+9K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+9K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+9K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+9K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+9K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+9K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+9K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+9K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+9K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+9K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+9K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+10K261279DeltaNEC Interbody SystemNexus Spine20260—
+10K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+10K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+10K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+10K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+10K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+10K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+10K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+10K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+10K223418DeGen Impulse AM™ SystemDegen Medical20236—
+10K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+10K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+10K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+10K213417Ghost Spacer SystemLife Spine, Inc.20220—
+10K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+10K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+10K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+10K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+10K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+10K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+10K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+10K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+10K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+11K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+11K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+11K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+11K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+11K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+11K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+11K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+11K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+11K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+11K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+11K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+11K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+11K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+11K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+12K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+12K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+12K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+12K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+12K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+12K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+12K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+13K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+13K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+13K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+14K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—