510(k) Report

Devices descending from K062810

835 later devices reach Solitaire Anterior Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+7K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+7K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+7K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+7K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+7K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+7K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+7K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+7K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+7K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+7K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+7K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+7K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K230583Tryptik TiSpineart SA20231—
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+7K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+7K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+7K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+7K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+7K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+7K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+7K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+7K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+7K211740DualXAmplify Surgical, Inc.20211—
+7K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+7K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+7K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+7K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+7K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+7K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+7K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+7K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+7K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+7K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+7K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+7K192897icotec Cervical CageIcotec AG20201—
+7K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K193521Steerable Plateau TiLife Spine, Inc.20201—
+7K193258ProLift Expandable SystemLife Spine, Inc.20203—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+7K183407Triton CageMedyssey USA, Inc.20190—
+7K183064TxTi IBF SystemInnovasis, Inc.2019481
+7K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+7K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+7K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+7K183092Kuros TLIF CageKuros Biosciences B.V20190—
+7K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+7K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+7K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+7K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+7K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+7K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+7K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+7K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+7K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—