510(k) Report

Devices descending from K071833

963 later devices reach Mosaic Devices through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+7K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+7K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+7K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+7K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+7K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+7K223326Axiom PSR SystemRestor3D202301
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+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—
+7K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+7K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+7K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+7K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+7K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+7K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+7K203444BEE HA CageNGMedical GmbH20211—
+7K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+7K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+7K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+7K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K201287Impulse Interbody Fusion SystemDegen Medical20208—
+7K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K193521Steerable Plateau TiLife Spine, Inc.20201—
+7K193258ProLift Expandable SystemLife Spine, Inc.20203—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+7K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K183243Velofix TLIF CageU&I Corporation20190—
+7K183064TxTi IBF SystemInnovasis, Inc.2019481
+7K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+7K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+7K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+7K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+7K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+7K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+7K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+7K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+7K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+7K181829Velofix TLIF CageU&I Corporation20181—
+7K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K181014Tritanium PL CageStryker Spine2018137—
+7K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+7K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+7K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+7K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K170235Lucent®Spinal Elements, Inc.2017107—
+7K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+7K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+7K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+7K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+7K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+7K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+7K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+7K160715AccuLIF TL and PL CageStryker Corporation20160—
+7K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+7K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+7K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K252322SIros-X SystemGenesys Spine20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—