Cleared Traditional

Reliance Spinal Screw System

K162066 · Reliance Medical Systems, LLC · Orthopedic
Dec 2016
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K162066 is an FDA 510(k) clearance for the Reliance Spinal Screw System, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Reliance Medical Systems, LLC (Bountiful, US). The FDA issued a Cleared decision on December 2, 2016, 129 days after receiving the submission on July 26, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K162066 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2016
Decision Date December 02, 2016
Days to Decision 129 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