Cleared Traditional

RELIANCE SPINAL SCREW SYSTEM

K081978 · Reliance Medical Systems, LLC · Orthopedic
Mar 2009
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K081978 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 (Sandy, US). The FDA issued a Cleared decision on March 26, 2009, 258 days after receiving the submission on July 11, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K081978 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2008
Decision Date March 26, 2009
Days to Decision 258 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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