510(k) Report

Devices descending from K082260

562 later devices reach Integra Cervical and Petra Plif Lumbar Cages through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K211413BEE PLIF CageNGMedical GmbH20211—
+8K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+8K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+8K203003Pantheon IBFDPantheon Spinal20210—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+8K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+8K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+8K202637F3D Corpectomy SystemCorelink, LLC20201—
+8K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K200316UNiD IB3D ALIFMedicrea International SA20200—
+8K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+8K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+8K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+8K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+8K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+8K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+8K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+8K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+8K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+8K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+9K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+9K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K260810Anteralign LS coverplateTyber Medical, LLC20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K253545Vulcan Spinal SystemK2m, Inc.20260—
+9K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+9K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+9K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+9K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+9K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+9K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K250556Porous Biologic ScaffoldVentris Medical20250—
+9K243188Cylox® STSignus Medizintechnik GmbH20250—
+9K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+9K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+9K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+9K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+9K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+9K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+9K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+9K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+9K240442MagnetOs PuttyKuros Biosciences B.V20243—
+9K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+9K240458Synthetic Bone PuttyVentris Medical20242—
+9K240459Cerament Bone Void FillerBonesupport AB20240—
+9K232347MagnetOs GranulesKuros Biosciences B.V20242—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+9K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+9K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+9K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+9K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+9K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+9K232315Catalyst Bone Void FillerOssdsign AB20237—
+9K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+9K223494CD Horizon Spinal SystemMedtronic202317—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+9K221578Hexanium ACIFSpinevision, S.A.S.20224—
+9K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+9K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+9K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+9K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+9K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+9K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+9K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+9K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+9K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+9K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+9K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+9K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+9K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+9K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+9K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—