510(k) Report

Devices descending from K021791

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K172816TiGer Shark™ SystemChoicespine, LP201859—
+5K171312FortiCore®Nanovis, LLC20183—
+5K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+5K173508Everest Spinal SystemK2m20189—
+5K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+5K173702Juliet Ti LLSpineart20182—
+5K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+5K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+5K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+5K172756Varian cageMedyssey USA, Inc.20171—
+5K173126Arisstos™ Spinal SystemIngenium Spine20171—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K172469TiLock Modular Spinal SystemGenesys Spine20170—
+5K172424Velofix™ SA Cervical CageU&I Corporation201751
+5K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+5K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+5K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+5K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+5K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+5K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+5K172065Scarlet AC-TSpineart20172—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+5K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+5K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+5K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+5K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+5K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+5K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+5K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+5K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+5K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+5K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+5K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+5K162496Foundation 3D InterbodyCorelink, LLC201782—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+5K170271NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated201712—
+5K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+5K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+5K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K162531Sterispine CCSafe Orthopaedics20160—
+5K163180Hubble IIOrbbo Surgical, LLC20160—
+5K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+5K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+5K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+5K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+5K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+5K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+5K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+5K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K161129Pillar SA PTCOrthofix, Inc.201619—
+5K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+5K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+5K161028K2M Growing Spine SystemK2m, Inc.20163—
+5K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K160631Keos Lumbar IBFDKeos20161—
+5K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+5K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+5K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+5K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+5K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+5K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+5K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+5K152568C-VBRCardinal Spine, LLC201657—
+5K151939COALITION SpacersGlobus Medical, Inc.2016152—
+5K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+5K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+5K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+5K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+5K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—