Cleared Traditional

Zevo Anterior Cervical Plate System

K231090 · Medtronic Sofamor Danek USA, Inc. · Orthopedic
Jun 2023
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K231090 is an FDA 510(k) clearance for the Zevo Anterior Cervical Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on June 15, 2023, 59 days after receiving the submission on April 17, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K231090 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2023
Decision Date June 15, 2023
Days to Decision 59 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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