510(k) Report

Devices descending from P970015

1,426 later devices reach Inter Fix Threaded Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+7K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+7K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K234150Lucent® XPSpinal Elements20240—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+7K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+7K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+7K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+7K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+7K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+7K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+7K230989Rod Registration FrameNu Vasive, Incorporated20230—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+7K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+7K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+7K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+7K190721LongBow TiLife Spine, Inc.20190—
+7K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+7K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+7K180376K2M Patient Specific RodsK2m, Inc.20182—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+7K171425Concorde LiftMedos International SARL201782
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K133402K2M Modular HooksK2m, Inc.20140—
+8K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K243188Cylox® STSignus Medizintechnik GmbH20250—
+8K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+8K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+8K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+8K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+8K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+8K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+8K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K191575ARx Spinal SystemLife Spine, Inc.201910—
+8K182349Concorde LiftMedos International SARL20190—
+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—
+8K173537Concorde Lift™Medos International SARL20181—