Cleared Traditional

CODA? Anterior Cervical Plate System

K222493 · Pioneer Surgical Technology, Inc. · Orthopedic
Nov 2022
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K222493 is an FDA 510(k) clearance for the CODA? Anterior Cervical Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on November 18, 2022, 92 days after receiving the submission on August 18, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K222493 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2022
Decision Date November 18, 2022
Days to Decision 92 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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