510(k) Report

Devices descending from K023675

482 later devices reach Synthes Cervifix/ Axon through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+7K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+7K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+7K133402K2M Modular HooksK2m, Inc.20140—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+8K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+8K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+8K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+8K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+8K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+8K222789VADER® Pedicle System, G21 CementIcotec AG202352
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+8K181188EVEREST Spinal SystemK2m, Inc.20186—
+8K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+8K171321K2M Navigation InstrumentsK2m201711
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+9K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+9K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+9K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K232628VADER® Pedicle SystemIcotec AG20241—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+10K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+11K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+11K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—