Cleared Special

RELIANCE VBS SYSTEM

K081383 · Reliance Medical Systems, LLC · Orthopedic
Jul 2008
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K081383 is an FDA 510(k) clearance for the RELIANCE VBS SYSTEM, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Reliance Medical Systems, LLC (Sandy, US). The FDA issued a Cleared decision on July 2, 2008, 47 days after receiving the submission on May 16, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K081383 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2008
Decision Date July 02, 2008
Days to Decision 47 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQP — Spinal Vertebral Body Replacement Device
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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