510(k) Report

Devices descending from K151214

220 later devices reach ALIF Interfixated System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+4K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K232315Catalyst Bone Void FillerOssdsign AB20237—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+4K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+5K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K243474MagnetOs MISKuros Biosciences B.V20250—
+5K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+5K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+5K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+5K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+5K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+5K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+5K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+5K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+5K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+5K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+5K240453ReBOSSISOrthorebirth Co., Ltd.202402
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+5K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261279DeltaNEC Interbody SystemNexus Spine20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K252742Navigated InstrumentsTyber Medical, LLC20251—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—