510(k) Report

Devices descending from K003836

1,330 later devices reach Synthes Synex Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+3K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+3K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—
+3K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+3K080728LDR Spine Roi-C ImplantLdr Spine USA2008903—
+3K080572LDR Spine Roi-a ImplantLdr Spine USA2008113—
+3K072537Creaspine Supstance Vertebral Body Replacement SystemCreaspine Sas20071—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K243188Cylox® STSignus Medizintechnik GmbH20250—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+4K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+4K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+4K223043The Integrity Spine Core SystemIntegrity Spine20230—
+4K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+4K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+4K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+4K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+4K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+4K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+4K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+4K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+4K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+4K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+4K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+4K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K190284Bengal Stackable Cage SystemMedos International SARL20190—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+4K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+4K190721LongBow TiLife Spine, Inc.20190—
+4K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+4K192117Small VBR™Ulrich GmbH & Co. KG20196—
+4K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+4K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K191778Omnia Medical VBROmnia Medical, LLC20195—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K190488ProLift Expandable SystemLife Spine, Inc.201916—
+4K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+4K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K182470Plateau Spacer SystemLife Spine20180—
+4K181818Scarlet AL-TSpineart201864—
+4K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+4K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+4K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+4K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+4K173148ACIFColigne AG20171—
+4K173022SeaSpine Ventura NanoMetalene SystemSeaSpine Orthopedics Corporation20170—
+4K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—