Cleared Special

Reliance Posterior Cervical-Thoracic System

K142867 · Reliance Medical Systems, LLC · Orthopedic
Apr 2015
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K142867 is an FDA 510(k) clearance for the Reliance Posterior Cervical-Thoracic System, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Reliance Medical Systems, LLC (Bountiful, US). The FDA issued a Cleared decision on April 29, 2015, 210 days after receiving the submission on October 1, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K142867 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2014
Decision Date April 29, 2015
Days to Decision 210 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWP — Appliance, Fixation, Spinal Interlaminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3050

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