Cleared Traditional

icotec Anterior Cervical Plate System

K201587 · Icotec AG · Orthopedic
Oct 2020
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K201587 is an FDA 510(k) clearance for the icotec Anterior Cervical Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Icotec AG (Altstaetten, CH). The FDA issued a Cleared decision on October 15, 2020, 126 days after receiving the submission on June 11, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K201587 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 2020
Decision Date October 15, 2020
Days to Decision 126 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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