510(k) Report

Devices descending from K062073

844 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+8K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+8K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+8K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+8K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+9K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+9K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K261067BEE PLIF CageNGMedical GmbH20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+9K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+9K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+9K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+9K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+9K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+9K211413BEE PLIF CageNGMedical GmbH20211—
+9K210728CONDUIT InstrumentsMedos International SARL20215—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+10K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+10K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K232014CONDUIT™ ATP InsertersEnztec Limited20230—