510(k) Report

Devices descending from K062083

1,252 later devices reach Synfix -LR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+8K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+8K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+8K182584Lucent® XPSpinal Elements, Inc.20183—
+8K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+8K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+8K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+8K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+8K181188EVEREST Spinal SystemK2m, Inc.20186—
+8K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+8K171321K2M Navigation InstrumentsK2m201711
+8K171425Concorde LiftMedos International SARL201782
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+9K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+9K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+9K234150Lucent® XPSpinal Elements20240—
+9K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+9K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+9K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+9K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+9K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+9K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+9K201006K2M Navigation InstrumentsK2m, Inc.20200—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K182349Concorde LiftMedos International SARL20190—
+9K173537Concorde Lift™Medos International SARL20181—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+10K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+10K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+10K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+10K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+11K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+11K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+11K230989Rod Registration FrameNu Vasive, Incorporated20230—
+12K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—