Cleared Traditional

Zavation Spinal System

K153404 · Zavation, LLC · Orthopedic
Apr 2016
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K153404 is an FDA 510(k) clearance for the Zavation Spinal System, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Zavation, LLC (Flowood, US). The FDA issued a Cleared decision on April 21, 2016, 149 days after receiving the submission on November 24, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K153404 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2015
Decision Date April 21, 2016
Days to Decision 149 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MNH — Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3070