Cleared Traditional

ZAVATION CERVICAL PLATE SYSTEM

K130030 · Zavation, LLC · Orthopedic
Apr 2013
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K130030 is an FDA 510(k) clearance for the ZAVATION CERVICAL PLATE SYSTEM, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Zavation, LLC (Brandon, US). The FDA issued a Cleared decision on April 25, 2013, 111 days after receiving the submission on January 4, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K130030 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 2013
Decision Date April 25, 2013
Days to Decision 111 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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