510(k) Report

Devices descending from K073320

1,018 later devices reach Cimplicity Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+9K183243Velofix TLIF CageU&I Corporation20190—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+10K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+11K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—