510(k) Report

Devices descending from K013382

1,110 later devices reach Modification to: Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+7K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+7K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K182608Oyster ACIF CageSilony Medical GmbH20190—
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+7K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+7K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+7K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+7K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+7K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+7K181014Tritanium PL CageStryker Spine2018137—
+7K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+7K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+7K172941CASCADIA Interbody SystemK2m201852—
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K172756Varian cageMedyssey USA, Inc.20171—
+7K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+7K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+7K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+7K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+7K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+7K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+7K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+7K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+7K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+7K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+7K160715AccuLIF TL and PL CageStryker Corporation20160—
+7K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+7K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+7K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+7K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+7K141217Acculif TL and PL CageStryker Corporation20146423
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+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—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+8K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K240715Idys® C ZP 3DTiClariance20240—
+8K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K230026SqualeImplanet, S.A.20230—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+8K223251Hexanium PLIFSpinevision, S.A.S.20220—
+8K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+8K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+8K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+8K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+8K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+8K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+9K253545Vulcan Spinal SystemK2m, Inc.20260—
+9K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+9K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—