Cleared Traditional

Romeo posterior osteosynthesis system

K151695 · Spineart · Orthopedic
Sep 2015
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K151695 is an FDA 510(k) clearance for the Romeo posterior osteosynthesis system, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Spineart (Geneva, CH). The FDA issued a Cleared decision on September 10, 2015, 79 days after receiving the submission on June 23, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K151695 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2015
Decision Date September 10, 2015
Days to Decision 79 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