510(k) Report

Devices descending from K143578

210 later devices reach SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+1K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+1K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+1K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+1K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+1K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+1K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+1K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+2K242303MOD-COrthomod, LLC20260—
+2K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+2K250560BEE HANGMedical GmbH20250—
+2K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+2K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+2K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+2K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+2K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+2K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+2K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+2K203444BEE HA CageNGMedical GmbH20211—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+2K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+2K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+2K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+2K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+2K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+2K201585Monterey AL Interbody SystemStryker Corporation202044
+2K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+2K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+2K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+2K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+2K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+2K190885Elevation Spine Saber-C SystemElevation Spine201925—
+2K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+2K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+2K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+2K180909REVEL SpacersGlobus Medical, Inc.201837—
+2K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+3K261049Scala® TLSpineart SA20260—
+3K261408SABER-XA SystemElevation Spine20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K260660SABER-C SystemElevation Spine20261—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+3K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+3K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+3K250769Dakota LP SystemPrecision Spine, Inc.20250—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K250540SABER-C SystemElevation Spine20252—
+3K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+3K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+3K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+3K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+3K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+3K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K230583Tryptik TiSpineart SA20231—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+3K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+3K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+3K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+3K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+3K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+3K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+3K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+3K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K211306LabyrinthZavation Medical Products, LLC20213—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—