510(k) Report

Devices descending from K083026

1,042 later devices reach Clydesdale Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+10K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K253545Vulcan Spinal SystemK2m, Inc.20260—
+10K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+10K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+10K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+10K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+10K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+10K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+10K212358Romero Cervical CageSpineup, Inc.20226—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+10K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+10K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+10K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+10K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+10K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+10K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+10K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+11K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+11K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+11K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+11K230026SqualeImplanet, S.A.20230—
+11K211306LabyrinthZavation Medical Products, LLC20213—
+11K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+11K171425Concorde LiftMedos International SARL201782
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+12K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+12K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+12K182349Concorde LiftMedos International SARL20190—
+12K173537Concorde Lift™Medos International SARL20181—
+13K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—