Cleared Traditional

DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM

K140417 · Medtronic Sofamor Danek, Inc. · Orthopedic
Jul 2014
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K140417 is an FDA 510(k) clearance for the DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on July 9, 2014, 141 days after receiving the submission on February 18, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K140417 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2014
Decision Date July 09, 2014
Days to Decision 141 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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