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
+6K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+6K171140Matrixx SystemNexxt Spine, LLC2017145—
+6K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+6K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+6K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+6K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+6K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+6K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+6K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+6K163364MOJAVE Expandable Interbody SystemK2m201725—
+6K162575Z-LINKPC SystemZavation, LLC20173—
+6K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+6K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+6K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+6K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+6K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+6K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+6K162262Tritanium® PL CageStryker2016132—
+6K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+6K162264Cascadia Interbody SystemK2m, Inc.2016169—
+6K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+6K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+6K160955Tritanium® PL CageStryker2016178—
+6K152622Alta ACDF SystemBiomet Spine20160—
+6K160715AccuLIF TL and PL CageStryker Corporation20160—
+6K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+6K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+6K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+6K151939COALITION SpacersGlobus Medical, Inc.2016152—
+6K150918PASS OCT Spinal SystemMedicrea International SA201513—
+6K143479Bluefin Interbody SystemTides Medical20152—
+6K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+6K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+6K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+6K141005Z-Link CervicalZavation, LLC20144—
+6K141284Caspian Spinal SystemK2m, Inc.20140—
+6K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+6K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+6K131833Centurion Poct SystemOrthofix, Inc.20142—
+6K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+6K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+6K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+6K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+6K120998Solstice Cross ConnectorLife Spine20121—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K263049SABER-C SystemElevation Spine20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+7K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+7K252322SIros-X SystemGenesys Spine20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243188Cylox® STSignus Medizintechnik GmbH20250—
+7K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+7K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+7K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+7K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+7K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+7K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+7K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402