510(k) Report

Devices descending from K060719

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+8K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+8K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+8K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+8K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+8K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+8K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+8K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+8K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+8K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+8K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+8K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+8K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+8K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+8K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+8K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+8K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+8K200303Reform Pedicle Screw SystemPrecision Spine202010—
+8K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+8K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+8K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+8K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+8K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+8K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+8K183064TxTi IBF SystemInnovasis, Inc.2019481
+8K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+8K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+8K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+8K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+8K183092Kuros TLIF CageKuros Biosciences B.V20190—
+8K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+8K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+8K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+8K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+8K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+8K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+8K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+8K180433Ennovate®Aesculap Implant Systems, LLC201811
+8K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+8K172816TiGer Shark™ SystemChoicespine, LP201859—
+8K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+8K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+8K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+8K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+8K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+8K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+8K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+8K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+8K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+8K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+8K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+9K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+9K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+9K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+9K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+9K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+9K240453ReBOSSISOrthorebirth Co., Ltd.202402
+9K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+9K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—