Cleared Traditional

K021335 - MONARCH SPINE SYSTEM
(FDA 510(k) Clearance)

K021335 · Depuyacromed · Orthopedic
Jul 2002
Decision
76d
Days
Class 2
Risk

K021335 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 July 11, 2002, 76 days after receiving the submission on April 26, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K021335 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2002
Decision Date July 11, 2002
Days to Decision 76 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