Cleared Special

EAGLE ANTERIOR CERVIAL PLATE SYSTEM

K040197 · Depuyacromed · Orthopedic
Apr 2004
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K040197 is an FDA 510(k) clearance for the EAGLE ANTERIOR CERVIAL PLATE SYSTEM, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on April 2, 2004, 64 days after receiving the submission on January 29, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K040197 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 2004
Decision Date April 02, 2004
Days to Decision 64 days
Submission Type Special
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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