Cleared Special

Reliance Spinal Screw System

K152131 · Reliance Medical Systems, LLC · Orthopedic
Sep 2015
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K152131 is an FDA 510(k) clearance for the Reliance Spinal Screw System, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Reliance Medical Systems, LLC (Bountiful, US). The FDA issued a Cleared decision on September 17, 2015, 48 days after receiving the submission on July 31, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K152131 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2015
Decision Date September 17, 2015
Days to Decision 48 days
Submission Type Special
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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