510(k) Report

Devices descending from K031914

1,530 later devices reach Spinal Concepts, Inc. Cadence and Fortitude through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+9K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+9K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+9K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+9K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+9K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+9K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+9K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+9K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+9K232315Catalyst Bone Void FillerOssdsign AB20237—
+9K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+9K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+9K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+9K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+9K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+9K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+9K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+9K213815SiJoin®T3Vgi Medical, Inc.20230—
+9K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+9K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+9K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+9K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+9K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+9K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+9K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+9K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+9K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+9K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+9K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+9K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+9K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+9K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+9K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+9K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+9K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+9K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+9K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+9K211740DualXAmplify Surgical, Inc.20211—
+9K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+9K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+9K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+9K210728CONDUIT InstrumentsMedos International SARL20215—
+9K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+9K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+9K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+9K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+9K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+9K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+9K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+9K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+9K193258ProLift Expandable SystemLife Spine, Inc.20203—
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+9K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+9K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+9K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+9K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+9K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+9K182608Oyster ACIF CageSilony Medical GmbH20190—
+9K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+9K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+9K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+9K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+9K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+9K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+9K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+9K180376K2M Patient Specific RodsK2m, Inc.20182—
+9K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+9K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+9K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+9K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+9K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+9K171519FLXfit™Expanding Orthopedics, Inc.2017711
+9K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+9K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+9K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+9K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+9K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+9K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+9K162262Tritanium® PL CageStryker2016132—
+9K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+9K161028K2M Growing Spine SystemK2m, Inc.20163—
+9K161369EVEREST Spinal SystemK2m, Incorporated20169—
+9K160955Tritanium® PL CageStryker2016178—
+9K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+9K160715AccuLIF TL and PL CageStryker Corporation20160—
+9K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+9K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+9K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+9K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+9K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—