Cleared Traditional

Skyway Anterior Cervical Plate System

K243015 · Kyocera Medical Technologies, Inc. · Orthopedic
Nov 2024
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K243015 is an FDA 510(k) clearance for the Skyway Anterior Cervical Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Kyocera Medical Technologies, Inc. (Redlands, US). The FDA issued a Cleared decision on November 5, 2024, 39 days after receiving the submission on September 27, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K243015 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2024
Decision Date November 05, 2024
Days to Decision 39 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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