510(k) Report

Devices descending from K041197

994 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+9K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+9K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+9K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K240442MagnetOs PuttyKuros Biosciences B.V20243—
+9K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+9K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+9K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+9K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+9K240458Synthetic Bone PuttyVentris Medical20242—
+9K240459Cerament Bone Void FillerBonesupport AB20240—
+9K232347MagnetOs GranulesKuros Biosciences B.V20242—
+9K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+9K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+9K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+9K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+9K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+9K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+9K232315Catalyst Bone Void FillerOssdsign AB20237—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+9K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+9K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+9K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+9K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+9K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+9K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+9K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+9K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+9K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+9K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+9K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+9K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+9K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+9K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+9K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+9K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+9K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+9K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+9K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+9K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+9K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+9K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+9K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+9K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+9K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+9K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+9K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+9K201287Impulse Interbody Fusion SystemDegen Medical20208—
+9K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+9K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+9K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+9K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+9K200303Reform Pedicle Screw SystemPrecision Spine202010—
+9K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+9K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+9K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+9K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+9K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+9K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+9K183064TxTi IBF SystemInnovasis, Inc.2019481
+9K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+9K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+9K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+9K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+9K183092Kuros TLIF CageKuros Biosciences B.V20190—
+9K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+9K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+9K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+9K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+9K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+9K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+9K180433Ennovate®Aesculap Implant Systems, LLC201811
+9K172816TiGer Shark™ SystemChoicespine, LP201859—
+9K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+9K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+9K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+9K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+9K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+9K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+9K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+9K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+9K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+9K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+10K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+10K261279DeltaNEC Interbody SystemNexus Spine20260—
+10K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+10K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+10K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+10K243474MagnetOs MISKuros Biosciences B.V20250—
+10K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+10K242797OsteoFlo HydroFiberSurGenTec, LLC20241—