FDA 510(k) Applications Submitted by Zimmer Biomet Spine, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K181096 04/26/2018 Avenue P Cage System Zimmer Biomet Spine, Inc.
K191722 06/27/2019 Vital Navigation System Zimmer Biomet Spine, Inc.
K192133 08/07/2019 Zimmer Biomet Universal Navigation System Zimmer Biomet Spine, Inc.
K203507 11/30/2020 Vitality« Spinal Fixation System Zimmer Biomet Spine, Inc.
K180227 01/26/2018 Polaris Spinal Growth System Zimmer Biomet Spine, Inc.
K183550 12/20/2018 Vitality« Spinal Fixation System Zimmer Biomet Spine, Inc.
K212023 06/29/2021 Virage Navigation System Zimmer Biomet Spine, Inc.
K202309 08/14/2020 Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System Zimmer Biomet Spine, Inc.
K190556 03/05/2019 Zimmer Biomet Universal Navigation System Zimmer Biomet Spine, Inc.
K171907 06/26/2017 Vitality« Spinal Fixation System Zimmer Biomet Spine, Inc.
K172275 07/28/2017 Vitality« Spinal Fixation System, Vitality«+ Power Instrument System Zimmer Biomet Spine, Inc.


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