510(k) Report

Devices descending from K080083

932 later devices reach Intrepid Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+8K182349Concorde LiftMedos International SARL20190—
+8K173537Concorde Lift™Medos International SARL20181—
+8K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+9K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K261067BEE PLIF CageNGMedical GmbH20260—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+9K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+9K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+9K211413BEE PLIF CageNGMedical GmbH20211—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+9K210728CONDUIT InstrumentsMedos International SARL20215—
+9K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+10K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+10K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+10K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K232014CONDUIT™ ATP InsertersEnztec Limited20230—