Cleared Traditional

RELIANCE ANTERIOR CERVICAL PLATE SYSTEM

K122216 · Reliance Medical Systems, LLC · Orthopedic
Sep 2012
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K122216 is an FDA 510(k) clearance for the RELIANCE ANTERIOR CERVICAL PLATE SYSTEM, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Reliance Medical Systems, LLC (Bountiful, US). The FDA issued a Cleared decision on September 5, 2012, 42 days after receiving the submission on July 25, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K122216 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2012
Decision Date September 05, 2012
Days to Decision 42 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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