510(k) Report

Devices descending from P950019

1,482 later devices reach Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+7K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+7K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K190885Elevation Spine Saber-C SystemElevation Spine201925—
+7K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+7K180909REVEL SpacersGlobus Medical, Inc.201837—
+7K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+7K172568CervagePrecifit Medical, Ltd.20181—
+7K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+7K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+7K171425Concorde LiftMedos International SARL201782
+7K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+7K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+7K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+7K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+7K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K260660SABER-C SystemElevation Spine20261—
+8K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+8K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K250540SABER-C SystemElevation Spine20252—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K243188Cylox® STSignus Medizintechnik GmbH20250—
+8K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+8K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+8K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+8K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+8K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+8K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+8K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+8K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+8K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+8K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+8K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+8K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+8K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+8K191575ARx Spinal SystemLife Spine, Inc.201910—
+8K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+8K182349Concorde LiftMedos International SARL20190—
+8K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+8K173537Concorde Lift™Medos International SARL20181—
+8K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+9K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+9K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+9K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+9K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+9K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+9K220025ARx® Spinal SystemLife Spine, Inc.20220—
+9K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+9K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+9K200070ARx Spinal SystemLife Spine, Inc.20209—
+9K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+10K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+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—
+10K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+10K210549ARx Spinal SystemLife Spine, Inc.20211—
+10K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+11K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—