510(k) Report

Devices descending from K012254

2,058 later devices reach VBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+6K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+6K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K172816TiGer Shark™ SystemChoicespine, LP201859—
+6K171312FortiCore®Nanovis, LLC20183—
+6K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+6K173508Everest Spinal SystemK2m20189—
+6K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+6K173702Juliet Ti LLSpineart20182—
+6K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+6K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+6K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+6K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+6K172756Varian cageMedyssey USA, Inc.20171—
+6K173126Arisstos™ Spinal SystemIngenium Spine20171—
+6K172419Velofix™ TLIF CageU&I Corporation20172—
+6K172469TiLock Modular Spinal SystemGenesys Spine20170—
+6K172424Velofix™ SA Cervical CageU&I Corporation201751
+6K172083Idys™ ALIF SystemClariance, Sas20177—
+6K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+6K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+6K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+6K172065Scarlet AC-TSpineart20172—
+6K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+6K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+6K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+6K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+6K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+6K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+6K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+6K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+6K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+6K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+6K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+6K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+6K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+6K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+6K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+6K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+6K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+6K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+6K162496Foundation 3D InterbodyCorelink, LLC201782—
+6K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+6K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+6K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+6K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+6K162921Navigated Instrument SystemOrthofix, Inc.20175—
+6K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+6K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+6K162786PASS LP Spinal SystemMedicrea International SA20176—
+6K162531Sterispine CCSafe Orthopaedics20160—
+6K163180Hubble IIOrbbo Surgical, LLC20160—
+6K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+6K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+6K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+6K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+6K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+6K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+6K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+6K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+6K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+6K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+6K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K161129Pillar SA PTCOrthofix, Inc.201619—
+6K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+6K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+6K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+6K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+6K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+6K160631Keos Lumbar IBFDKeos20161—
+6K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+6K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+6K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+6K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+6K153404Zavation Spinal SystemZavation, LLC20161—
+6K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+6K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+6K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+6K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+6K151939COALITION SpacersGlobus Medical, Inc.2016152—
+6K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+6K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+6K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+6K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+6K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—