510(k) Report

Devices descending from K022143

968 later devices reach Interpore Cross International Anterior Fixation Device (Afd) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+7K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+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—
+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—
+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—
+7K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+7K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+7K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+7K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+7K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+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—
+7K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+7K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+7K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+7K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+7K211740DualXAmplify Surgical, Inc.20211—
+7K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+7K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+7K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K203444BEE HA CageNGMedical GmbH20211—
+7K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+7K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+7K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+7K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+7K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+7K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+7K192897icotec Cervical CageIcotec AG20201—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K193258ProLift Expandable SystemLife Spine, Inc.20203—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+7K183064TxTi IBF SystemInnovasis, Inc.2019481
+7K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+7K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+7K182608Oyster ACIF CageSilony Medical GmbH20190—
+7K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+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—
+7K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+7K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+7K181829Velofix TLIF CageU&I Corporation20181—
+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—
+7K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+7K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+7K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+7K172419Velofix™ TLIF CageU&I Corporation20172—
+7K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+7K170235Lucent®Spinal Elements, Inc.2017107—
+7K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+7K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K250560BEE HANGMedical GmbH20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—