Cleared Special

MONARCH SPINE SYSTEM

K024348 · Depuyacromed · Orthopedic
Jan 2003
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K024348 is an FDA 510(k) clearance for the MONARCH SPINE SYSTEM, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on January 28, 2003, 29 days after receiving the submission on December 30, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K024348 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2002
Decision Date January 28, 2003
Days to Decision 29 days
Submission Type Special
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