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
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+5K202637F3D Corpectomy SystemCorelink, LLC20201—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K201585Monterey AL Interbody SystemStryker Corporation202044
+5K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+5K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+5K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+5K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+5K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+5K192906Mecta-C Stand AloneMedacta International S.A.20201—
+5K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K191134IB3D AlifMedicrea International SA20191—
+5K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+5K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+5K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+5K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K190680Favo S-TlifSilony Medical GmbH20190—
+5K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+5K182608Oyster ACIF CageSilony Medical GmbH20190—
+5K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+5K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+5K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+5K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+5K182477Cervical SpacerAdditive Implants, LLC201915—
+5K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+5K180909REVEL SpacersGlobus Medical, Inc.201837—
+5K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+5K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+5K181818Scarlet AL-TSpineart201864—
+5K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+5K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+5K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+5K180695FBC 921 (Alif)Fbc Device Aps20180—
+5K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+5K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+5K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+5K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+5K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+5K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K161129Pillar SA PTCOrthofix, Inc.201619—
+5K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+5K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+5K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+5K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+5K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+5K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+5K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+5K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+5K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+5K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261049Scala® TLSpineart SA20260—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K261408SABER-XA SystemElevation Spine20260—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K260660SABER-C SystemElevation Spine20261—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K250540SABER-C SystemElevation Spine20252—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—