510(k) Report

Devices descending from K003836

1,330 later devices reach Synthes Synex Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K201006K2M Navigation InstrumentsK2m, Inc.20200—
+9K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+9K182584Lucent® XPSpinal Elements, Inc.20183—
+9K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+9K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+9K171425Concorde LiftMedos International SARL201782
+9K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+9K162262Tritanium® PL CageStryker2016132—
+9K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+9K160955Tritanium® PL CageStryker2016178—
+9K160715AccuLIF TL and PL CageStryker Corporation20160—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+10K234150Lucent® XPSpinal Elements20240—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+10K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+10K182349Concorde LiftMedos International SARL20190—
+10K181014Tritanium PL CageStryker Spine2018137—
+10K173537Concorde Lift™Medos International SARL20181—
+11K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—