510(k) Report

Devices descending from K071983

788 later devices reach Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+4K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+4K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+4K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+4K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+4K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+4K1421124WEB Spinal Implant Products4Web, Inc.201433—
+4K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+5K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+5K242303MOD-COrthomod, LLC20260—
+5K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K250560BEE HANGMedical GmbH20250—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+5K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+5K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+5K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+5K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+5K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+5K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+5K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+5K223326Axiom PSR SystemRestor3D202301
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+5K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+5K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+5K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+5K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+5K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+5K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+5K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+5K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+5K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+5K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+5K212562Idys-C ZP 3DTiClariance, SA20211—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+5K201793EDEN Peek CageJmt Co., Ltd.20210—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+5K203444BEE HA CageNGMedical GmbH20211—
+5K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—