510(k) Report

Devices descending from K130573

251 later devices reach Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+1K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+1K183092Kuros TLIF CageKuros Biosciences B.V20190—
+1K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+1K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+1K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+1K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+1K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+1K150847Foundation Interbody DevicesCorelink, LLC201529—
+1K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+1K133967Interbody Cage SystemAurora Spine2014227—
+2K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+2K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+2K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+2K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+2K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+2K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+2K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+2K230583Tryptik TiSpineart SA20231—
+2K223043The Integrity Spine Core SystemIntegrity Spine20230—
+2K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+2K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+2K192897icotec Cervical CageIcotec AG20201—
+2K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+2K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+2K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+2K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+2K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+2K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+2K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+2K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+3K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+3K250769Dakota LP SystemPrecision Spine, Inc.20250—
+3K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+3K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+3K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+3K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+3K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+3K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+3K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K242303MOD-COrthomod, LLC20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K250560BEE HANGMedical GmbH20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+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—
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+4K223326Axiom PSR SystemRestor3D202301
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+4K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K203444BEE HA CageNGMedical GmbH20211—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—