510(k) Report

Devices descending from K072415

948 later devices reach Stalif (TM) C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+7K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+7K192897icotec Cervical CageIcotec AG20201—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K1803473d CageFims Co., Ltd.20190—
+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—
+7K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+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—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K243188Cylox® STSignus Medizintechnik GmbH20250—
+8K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+8K234150Lucent® XPSpinal Elements20240—
+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—
+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—
+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—
+9K261067BEE PLIF CageNGMedical GmbH20260—
+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—
+9K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+9K211413BEE PLIF CageNGMedical GmbH20211—
+9K210728CONDUIT InstrumentsMedos International SARL20215—
+9K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+10K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K232014CONDUIT™ ATP InsertersEnztec Limited20230—