510(k) Report

Devices descending from K021791

2,047 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K162262Tritanium® PL CageStryker2016132—
+7K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+7K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+7K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+7K160955Tritanium® PL CageStryker2016178—
+7K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+7K160715AccuLIF TL and PL CageStryker Corporation20160—
+7K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+7K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+7K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+7K150918PASS OCT Spinal SystemMedicrea International SA201513—
+7K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+7K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+7K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+7K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+7K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+7K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+7K141284Caspian Spinal SystemK2m, Inc.20140—
+7K141217Acculif TL and PL CageStryker Corporation20146423
+7K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+7K131833Centurion Poct SystemOrthofix, Inc.20142—
+7K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+7K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+7K120998Solstice Cross ConnectorLife Spine20121—
+8K263049SABER-C SystemElevation Spine20260—
+8K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+8K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+8K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+8K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243474MagnetOs MISKuros Biosciences B.V20250—
+8K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+8K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K240526POWEReam Xia/SerratoStryker Instruments20240—
+8K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+8K234150Lucent® XPSpinal Elements20240—
+8K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+8K240453ReBOSSISOrthorebirth Co., Ltd.202402
+8K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+8K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+8K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K222789VADER® Pedicle System, G21 CementIcotec AG202352
+8K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+8K223294SpineJack® Expansion KitStryker Instruments20221—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+8K222698CUVIS-spineCurexo, Inc.20220—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+8K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+8K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+8K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+8K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+8K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+8K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+8K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+8K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+8K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+8K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+8K181014Tritanium PL CageStryker Spine2018137—
+8K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+8K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+8K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+8K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+8K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+8K172194Connector SystemOrthofix, Inc.2017162