Cleared Traditional

Z-Span Plate System

K162824 · Zavation, LLC · Orthopedic
Feb 2017
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K162824 is an FDA 510(k) clearance for the Z-Span Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Zavation, LLC (Flowood, US). The FDA issued a Cleared decision on February 17, 2017, 133 days after receiving the submission on October 7, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K162824 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2016
Decision Date February 17, 2017
Days to Decision 133 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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