510(k) Report

Devices descending from K072970

1,094 later devices reach Patriot Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+3K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+3K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+3K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+3K223251Hexanium PLIFSpinevision, S.A.S.20220—
+3K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+3K222797X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20221—
+3K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+3K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+3K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+3K221687Pegasus-X Expandable PLIF SystemGS Medical Co., Ltd.20220—
+3K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+3K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+3K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+3K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+3K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+3K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+3K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+3K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+3K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K201087CORBEL SpacersGlobus Medical, Inc.202036—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+3K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+3K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+3K190284Bengal Stackable Cage SystemMedos International SARL20190—
+3K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+3K191796Neo Cage SystemNeo Medical SA20190—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+3K190721LongBow TiLife Spine, Inc.20190—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+3K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+3K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+3K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+3K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+3K190885Elevation Spine Saber-C SystemElevation Spine201925—
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K190488ProLift Expandable SystemLife Spine, Inc.201916—
+3K183243Velofix TLIF CageU&I Corporation20190—
+3K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+3K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—