510(k) Report

Devices descending from K030736

1,101 later devices reach Verte-Stack Spinal System, Extra Small Sizes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+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—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+9K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, 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—
+9K261067BEE PLIF CageNGMedical GmbH20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K253545Vulcan Spinal SystemK2m, Inc.20260—
+9K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+9K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+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—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+9K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+9K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+9K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+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—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+9K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+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—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+9K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+9K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+9K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+9K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+9K220025ARx® Spinal SystemLife Spine, Inc.20220—
+9K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+9K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+9K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+9K211413BEE PLIF CageNGMedical GmbH20211—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+9K210728CONDUIT InstrumentsMedos International SARL20215—
+9K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+9K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+9K201287Impulse Interbody Fusion SystemDegen Medical20208—
+9K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+9K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+9K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+9K191575ARx Spinal SystemLife Spine, Inc.201910—
+9K190680Favo S-TlifSilony Medical GmbH20190—
+9K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+9K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+9K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+10K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+10K233256Robotic Integration InstrumentsDePuy Synthes20240—
+10K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+10K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+10K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+10K200070ARx Spinal SystemLife Spine, Inc.20209—
+11K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+11K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+11K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+11K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+11K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+11K210549ARx Spinal SystemLife Spine, Inc.20211—
+11K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+12K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—