510(k) Report

Devices descending from K032534

43 later devices reach Synthes Afs through their predicates, nearest generation first.

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