510(k) Report

Devices descending from K094025

838 later devices reach Crescent Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K253545Vulcan Spinal SystemK2m, Inc.20260—
+9K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+9K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+9K212358Romero Cervical CageSpineup, Inc.20226—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+9K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+9K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+9K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+9K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+9K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+9K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+9K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+10K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+10K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+10K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+10K230026SqualeImplanet, S.A.20230—
+10K211306LabyrinthZavation Medical Products, LLC20213—
+10K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+10K171425Concorde LiftMedos International SARL201782
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+11K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+11K182349Concorde LiftMedos International SARL20190—
+11K173537Concorde Lift™Medos International SARL20181—
+12K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—