510(k) Report

Devices descending from K030377

391 later devices reach Modification to Synthes Cervifix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+8K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K222698CUVIS-spineCurexo, Inc.20220—
+8K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+8K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+8K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+8K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+8K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+8K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+8K181188EVEREST Spinal SystemK2m, Inc.20186—
+8K171321K2M Navigation InstrumentsK2m201711
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+9K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+9K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+9K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+9K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+9K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+9K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+9K222789VADER® Pedicle System, G21 CementIcotec AG202352
+9K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+9K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+9K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+9K201006K2M Navigation InstrumentsK2m, Inc.20200—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+10K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+10K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+10K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+10K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+10K232628VADER® Pedicle SystemIcotec AG20241—
+10K232432E3D™-A Interbody SystemEvolution Spine20248—
+10K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+10K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+10K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+11K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+11K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+11K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+11K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+11K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+11K240368E3D™-A Interbody SystemEvolution Spine20247—
+11K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+11K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+11K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+11K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+11K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+12K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+12K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+12K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—