510(k) Report

Devices descending from P970015

1,426 later devices reach Inter Fix Threaded Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K261430TruLift Expandable SystemLife Spine, Inc.20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+6K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+6K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+6K243474MagnetOs MISKuros Biosciences B.V20250—
+6K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+6K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+6K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+6K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+6K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+6K241895Cannulated PsiFGuardSpineguard20240—
+6K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+6K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+6K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+6K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+6K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+6K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+6K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+6K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+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—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+6K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+6K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+6K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+6K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+6K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+6K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+6K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+6K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+6K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+6K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+6K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+6K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+6K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+6K213815SiJoin®T3Vgi Medical, Inc.20230—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+6K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+6K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+6K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+6K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+6K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+6K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K221578Hexanium ACIFSpinevision, S.A.S.20224—
+6K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+6K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+6K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+6K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+6K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+6K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+6K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K210574NuVasive Pulse SystemNu Vasive, Incorporated202121