510(k) Report

Devices descending from K041556

1,002 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+5K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+5K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+5K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+5K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+5K160125Cascadia Interbody SystemK2m2016315—
+5K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+5K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+5K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+5K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+5K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+5K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+5K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+5K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+5K142487Chesapeake Stabilization SystemK2m, Inc.201571
+5K143616AccuLIF TL and PL CageStryker Corporation20154694
+5K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+5K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+5K141896Coroent SystemNu Vasive, Incorporated2014480—
+5K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+5K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+5K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+5K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+5K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+5K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+5K130853Idys (TM) CClariance20132—
+5K131449Coalition SpacerGlobus Medical, Inc.2013235—
+5K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+5K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp201230—
+5K113252Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2012306—
+5K112388Lanx Cervical SALanx, Inc.201126—
+5K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+5K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+5K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+5K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+5K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+5K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+6K261408SABER-XA SystemElevation Spine20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260660SABER-C SystemElevation Spine20261—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K242303MOD-COrthomod, LLC20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K250560BEE HANGMedical GmbH20250—
+6K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K250540SABER-C SystemElevation Spine20252—
+6K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+6K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+6K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+6K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+6K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+6K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+6K240699SCARLET® AC-TiSpineart SA20240—
+6K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+6K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+6K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+6K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+6K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+6K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+6K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+6K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+6K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+6K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+6K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+6K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+6K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+6K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+6K212562Idys-C ZP 3DTiClariance, SA20211—
+6K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—