510(k) Report

Devices descending from K100175

1,008 later devices reach Clydesdale Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+11K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+11K182349Concorde LiftMedos International SARL20190—
+11K173537Concorde Lift™Medos International SARL20181—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+12K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+12K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+12K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—