Home / 510(k) Clearances / K202309

510(k) K202309

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 by Zimmer Biomet Spine, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2020
Date Received
August 14, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

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  • K183550 — Vitality® Spinal Fixation System (April 8, 2019)
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  • K180227 — Polaris Spinal Growth System (March 15, 2018)

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