510(k) Report

Devices descending from K081395

854 later devices reach Solitaire Peek-Optima Anterior Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+6K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+6K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+6K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+6K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+6K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+6K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+6K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+6K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+6K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+6K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+6K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+6K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+6K240453ReBOSSISOrthorebirth Co., Ltd.202402
+6K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+6K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+6K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+6K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+6K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+6K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+6K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+6K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+6K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+6K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+6K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+6K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+6K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+6K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+6K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+6K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+6K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+6K221172FOCUS Interbody SystemOc Medical Devices20220—
+6K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+6K213417Ghost Spacer SystemLife Spine, Inc.20220—
+6K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+6K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+6K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+6K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+6K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+6K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+6K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+6K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+6K203003Pantheon IBFDPantheon Spinal20210—
+6K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+6K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+6K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+6K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+6K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+6K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+6K210359Hexanium TLIFSpinevision, S.A.S.20211—
+6K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+6K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+6K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+6K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+6K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+6K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+6K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+6K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+6K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+6K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+6K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+6K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+6K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+6K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+6K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—