510(k) Report

Devices descending from K850631

48 later devices reach Kirschner Orthopedic Wire, Eyelet Cerclage Wires through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050082Centerpiece Plate Fixation SystemMedtronic Sofamor Danek, Inc.200531—
+1K032534Synthes AfsSynthes Spine200443—
+1K011451Reunite Fusion ScrewBiomet, Inc.20010—
+2K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+2K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC20240—
+2K232471Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC20231—
+2K231232Curiteva Laminoplasty SystemCuriteva, Inc.20232—
+2K212428Centerpiece Plate Fixation SystemMedtronic Sofamor Danek20211—
+2K191927Hinged Laminoplasty SystemLife Spine, Inc.20190—
+2K191169NuVasive® Camber Laminoplasty SystemNu Vasive, Incorporated20191—
+2K181717Life Spine Laminoplasty SystemLife Spine, Inc.20181—
+2K173215Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP20184—
+2K132740Spinefrontier Lesplasty Posterior Cervical Laminoplasty SystemSpinefrontier, Inc.20130—
+2K122822Spectrum Spine Laminoplasty Plating SystemSpectrum Spine, LLC20135—
+2K121732Canopy Laminoplasty Fixation SystemGlobus Medical, Inc.201210—
+2K121276Neuro Vention Laminplasty Plating SystemNeurovention, LLC20120—
+2K111048Synthes Scout Tack FixationSynthes Spine20120—
+2K113802Escalate Laminoplasty SystemStryker Spine20127—
+2K113218Pioneer Release Laminoplasty Plating SystemPioneer Surgical Technology, Inc.20121—
+2K103284Laminoplasy Plating SystemAesculap Implant Systems, Inc.20101—
+2K100805Gallery Laminoplasty Fixation SystemBiomet Spine (Aka Ebi, LLC)20103—
+2K091994Mountaineer Laminoplasty SystemDepuy Spine, Inc.201017—
+2K091623Laminoplasty Fixation SystemNuvasive, Inc.20097—
+2K090354Laminoplasty Plating SystemAesculap Implant System, Inc.20092—
+2K080664Relieve Laminoplasty Fixation SystemGlobus Medical, Inc.200811—
+2K043338Blakstone Laminoplasty Fixation SystemBlackstone Medical, Inc.200517—
+3K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc.20241—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+3K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc.20200—
+3K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+3K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+3K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+3K171413HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc.20176—
+3K160114Xspan Laminoplasty Fixation SystemX-Spine Systems, Inc.20160—
+3K153735Release Laminoplasty Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20160—
+3K130830Integra Laminoplasty SystemSeaspine, Inc.20132—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+4K150469Integra Laminoplasty SystemSeaspine, Inc.20151—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—