Cleared Special

MODIFICATION TO MONARCH SPINE SYSTEM

K023438 · Depuyacromed · Orthopedic
Nov 2002
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K023438 is an FDA 510(k) clearance for the MODIFICATION TO 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 November 13, 2002, 29 days after receiving the submission on October 15, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K023438 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2002
Decision Date November 13, 2002
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