510(k) Report

Devices descending from K043338

17 later devices reach Blakstone Laminoplasty Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+1K100805Gallery Laminoplasty Fixation SystemBiomet Spine (Aka Ebi, LLC)20103—
+1K080664Relieve Laminoplasty Fixation SystemGlobus Medical, Inc.200811—
+2K232471Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC20231—
+2K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc.20200—
+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—
+2K121732Canopy Laminoplasty Fixation SystemGlobus Medical, Inc.201210—
+3K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC20240—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K231232Curiteva Laminoplasty SystemCuriteva, Inc.20232—
+3K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+4K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc.20241—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—