510(k) Report

Devices descending from K091994

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+1K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+1K173215Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP20184—
+1K171413HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc.20176—
+1K153735Release Laminoplasty Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20160—
+1K121732Canopy Laminoplasty Fixation SystemGlobus Medical, Inc.201210—
+1K113218Pioneer Release Laminoplasty Plating SystemPioneer Surgical Technology, Inc.20121—
+2K231232Curiteva Laminoplasty SystemCuriteva, Inc.20232—
+2K191927Hinged Laminoplasty SystemLife Spine, Inc.20190—
+2K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+3K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc.20241—
+3K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—