510(k) Report

Devices descending from K051027

908 later devices reach Stalif TT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+7K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+7K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+7K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+7K230026SqualeImplanet, S.A.20230—
+7K230583Tryptik TiSpineart SA20231—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+7K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+7K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+7K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+7K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+7K201287Impulse Interbody Fusion SystemDegen Medical20208—
+7K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+7K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+7K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+7K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+7K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+7K192897icotec Cervical CageIcotec AG20201—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K1803473d CageFims Co., Ltd.20190—
+7K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+7K183092Kuros TLIF CageKuros Biosciences B.V20190—
+7K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+7K182584Lucent® XPSpinal Elements, Inc.20183—
+7K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+7K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+7K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+7K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+7K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+7K171425Concorde LiftMedos International SARL201782
+7K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+7K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K243188Cylox® STSignus Medizintechnik GmbH20250—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K234150Lucent® XPSpinal Elements20240—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+8K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+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—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+9K261067BEE PLIF CageNGMedical GmbH20260—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+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—
+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—