510(k) Report

Devices descending from K031302

911 later devices reach Sustain Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K261408SABER-XA SystemElevation Spine20260—
+4K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K260660SABER-C SystemElevation Spine20261—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K242303MOD-COrthomod, LLC20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K250540SABER-C SystemElevation Spine20252—
+4K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K230583Tryptik TiSpineart SA20231—
+4K223418DeGen Impulse AM™ SystemDegen Medical20236—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+4K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+4K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+4K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+4K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+4K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+4K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+4K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K201087CORBEL SpacersGlobus Medical, Inc.202036—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+4K192897icotec Cervical CageIcotec AG20201—
+4K190284Bengal Stackable Cage SystemMedos International SARL20190—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+4K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+4K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+4K182470Plateau Spacer SystemLife Spine20180—
+4K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+4K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+4K173800Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy CageCamber Spine Technologies20180—
+4K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+4K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+4K171704CAPRI Corpectomy Cage SystemK2m201710—
+4K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+4K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.20170—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+4K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+4K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+4K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+4K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—