510(k) Report

Devices descending from K082262

722 later devices reach LDR Spine Roi Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+7K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+7K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+7K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+7K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+7K250556Porous Biologic ScaffoldVentris Medical20250—
+7K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+7K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+7K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+7K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+7K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+7K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+7K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+7K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+7K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+7K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+7K240442MagnetOs PuttyKuros Biosciences B.V20243—
+7K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K240458Synthetic Bone PuttyVentris Medical20242—
+7K240459Cerament Bone Void FillerBonesupport AB20240—
+7K232347MagnetOs GranulesKuros Biosciences B.V20242—
+7K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+7K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+7K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+7K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+7K232315Catalyst Bone Void FillerOssdsign AB20237—
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+7K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+7K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+7K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+7K230026SqualeImplanet, S.A.20230—
+7K230583Tryptik TiSpineart SA20231—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+7K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+7K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+7K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+7K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+7K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+7K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+7K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+7K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+7K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+7K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+7K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+7K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+7K192897icotec Cervical CageIcotec AG20201—
+7K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K193521Steerable Plateau TiLife Spine, Inc.20201—
+7K193258ProLift Expandable SystemLife Spine, Inc.20203—
+7K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+7K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+7K183064TxTi IBF SystemInnovasis, Inc.2019481
+7K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+7K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+7K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+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—
+7K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+7K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+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—