Cleared Traditional

RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM

K122292 · Reliance Medical Systems, LLC · Orthopedic
Oct 2012
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K122292 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 October 24, 2012, 85 days after receiving the submission on July 31, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K122292 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2012
Decision Date October 24, 2012
Days to Decision 85 days
Submission Type Traditional
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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