510(k) Report

Devices descending from K010930

2,053 later devices reach Lift VB Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+8K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+8K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+8K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+8K162575Z-LINKPC SystemZavation, LLC20173—
+8K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+8K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+8K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+8K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+8K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+8K162262Tritanium® PL CageStryker2016132—
+8K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+8K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+8K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+8K160955Tritanium® PL CageStryker2016178—
+8K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+8K160715AccuLIF TL and PL CageStryker Corporation20160—
+8K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+8K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+8K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+8K150918PASS OCT Spinal SystemMedicrea International SA201513—
+8K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+8K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+8K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+8K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+8K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+8K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+8K141284Caspian Spinal SystemK2m, Inc.20140—
+8K141217Acculif TL and PL CageStryker Corporation20146423
+8K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+8K131833Centurion Poct SystemOrthofix, Inc.20142—
+8K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+8K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+8K120998Solstice Cross ConnectorLife Spine20121—
+9K263049SABER-C SystemElevation Spine20260—
+9K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K240526POWEReam Xia/SerratoStryker Instruments20240—
+9K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+9K234150Lucent® XPSpinal Elements20240—
+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—
+9K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+9K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+9K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+9K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+9K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+9K222789VADER® Pedicle System, G21 CementIcotec AG202352
+9K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+9K223294SpineJack® Expansion KitStryker Instruments20221—
+9K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+9K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+9K222698CUVIS-spineCurexo, Inc.20220—
+9K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+9K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+9K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+9K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+9K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+9K210728CONDUIT InstrumentsMedos International SARL20215—
+9K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+9K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+9K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+9K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+9K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K193129Yukon OCT Spinal SystemK2m, Inc.202001
+9K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+9K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+9K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+9K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+9K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+9K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+9K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—