510(k) Report

Devices descending from K020048

1,559 later devices reach Modification to Geo Structure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+11K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+11K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+11K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+11K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+11K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+11K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+11K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+11K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+11K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+11K181014Tritanium PL CageStryker Spine2018137—
+11K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+11K181188EVEREST Spinal SystemK2m, Inc.20186—
+11K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+11K171321K2M Navigation InstrumentsK2m201711
+11K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+11K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+11K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+11K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+11K152622Alta ACDF SystemBiomet Spine20160—
+11K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+12K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+12K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+12K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+12K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+12K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+12K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+12K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+12K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+12K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+12K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+12K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+12K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+12K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+12K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+12K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+12K201006K2M Navigation InstrumentsK2m, Inc.20200—
+12K191575ARx Spinal SystemLife Spine, Inc.201910—
+12K171425Concorde LiftMedos International SARL201782
+13K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+13K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+13K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+13K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+13K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+13K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+13K220025ARx® Spinal SystemLife Spine, Inc.20220—
+13K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+13K200070ARx Spinal SystemLife Spine, Inc.20209—
+13K182349Concorde LiftMedos International SARL20190—
+13K173537Concorde Lift™Medos International SARL20181—
+14K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+14K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+14K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+14K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+14K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+14K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+14K210549ARx Spinal SystemLife Spine, Inc.20211—
+14K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+15K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—