510(k) Report

Devices descending from K110543

808 later devices reach Crescent (R) Spinal System Titanium through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+10K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+10K182349Concorde LiftMedos International SARL20190—
+10K173537Concorde Lift™Medos International SARL20181—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+11K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+11K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—