510(k) Report

Devices descending from K090887

644 later devices reach Orio-C Cervical, Orio-TL Tlif, Orio-PL Plif, Orio-AL Alif Intervedrtebral Body… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+6K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+6K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+6K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+6K230329F3D Interbody SystemCorelink, LLC20230—
+6K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+6K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+6K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+6K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+6K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+6K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+6K211740DualXAmplify Surgical, Inc.20211—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+6K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+6K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+6K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+6K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+6K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+6K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+6K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+6K193521Steerable Plateau TiLife Spine, Inc.20201—
+6K193258ProLift Expandable SystemLife Spine, Inc.20203—
+6K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+6K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+6K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+6K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+6K183064TxTi IBF SystemInnovasis, Inc.2019481
+6K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+6K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+6K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+6K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+6K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+6K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+6K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+6K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+6K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+6K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+6K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+6K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+6K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+6K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+6K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+6K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K170235Lucent®Spinal Elements, Inc.2017107—
+6K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+6K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+6K171496Tritanium C Anterior Cervical CageStryker Spine2017129—