510(k) Report

Devices descending from K140319

590 later devices reach Coroent TI-C System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+4K240453ReBOSSISOrthorebirth Co., Ltd.202402
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+4K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+4K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+4K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+4K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+4K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+4K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+4K223326Axiom PSR SystemRestor3D202301
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+4K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+4K211740DualXAmplify Surgical, Inc.20211—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+4K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+4K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K201087CORBEL SpacersGlobus Medical, Inc.202036—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+4K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+4K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+4K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+4K193521Steerable Plateau TiLife Spine, Inc.20201—
+4K193258ProLift Expandable SystemLife Spine, Inc.20203—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K183064TxTi IBF SystemInnovasis, Inc.2019481
+4K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+4K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+4K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+4K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+4K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+4K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+4K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—