Cleared Traditional

ZAVATION SPINAL SYSTEM

K112484 · Zavation, LLC · Orthopedic
Nov 2011
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K112484 is an FDA 510(k) clearance for the ZAVATION SPINAL SYSTEM, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Zavation, LLC (Brandon, US). The FDA issued a Cleared decision on November 22, 2011, 85 days after receiving the submission on August 29, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K112484 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2011
Decision Date November 22, 2011
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

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

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