510(k) Report

Devices descending from K011406

2,048 later devices reach Spinal Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+9K172194Connector SystemOrthofix, Inc.2017162
+9K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+9K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+9K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+9K161149PASS OCT Spinal SystemMedicrea International SA20160—
+9K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+9K160756PASS OCT Spinal SystemMedicrea International SA20160—
+9K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+9K153169PASS OCT Patient Specific RodsMedicrea International20164—
+9K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+9K152211PCT SystemCentinel Spine, Inc.20150—
+9K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+9K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+9K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+9K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+10K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+10K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+10K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K250637VCFix Spinal SystemAmber Implants20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+10K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+10K232628VADER® Pedicle SystemIcotec AG20241—
+10K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+10K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+10K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+10K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+10K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+10K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+10K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+10K190751Connector SystemOrthofix, Inc.20193—
+10K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+10K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+10K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+10K171425Concorde LiftMedos International SARL201782
+11K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+11K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+11K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+11K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+11K182349Concorde LiftMedos International SARL20190—
+11K173537Concorde Lift™Medos International SARL20181—