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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