510(k) Report

Devices descending from K042571

894 later devices reach Stryker Spine Avs TL Peek Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+7K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+7K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+7K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+7K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K223326Axiom PSR SystemRestor3D202301
+7K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+7K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+7K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+7K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+7K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+7K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+7K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+7K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+7K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+7K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+7K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+7K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K212562Idys-C ZP 3DTiClariance, SA20211—
+7K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+7K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+7K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+7K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+7K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+7K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+7K201087CORBEL SpacersGlobus Medical, Inc.202036—
+7K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+7K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+7K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+7K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+7K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+7K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K181818Scarlet AL-TSpineart201864—
+7K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+7K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+7K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+7K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+7K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+7K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+7K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+7K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+7K163595IMPIX 3D Print CagesMedicrea International SA2017282
+7K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+7K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+7K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+7K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+7K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+7K161379ELSA SpacersGlobus Medical, Inc.2016155—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+7K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+7K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+7K152622Alta ACDF SystemBiomet Spine20160—
+7K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+8K263049SABER-C SystemElevation Spine20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—