Cleared Special

K021148 - MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD
(FDA 510(k) Clearance)

K021148 · Depuyacromed · Orthopedic
May 2002
Decision
28d
Days
Class 2
Risk

K021148 is an FDA 510(k) clearance for the MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on May 8, 2002, 28 days after receiving the submission on April 10, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K021148 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2002
Decision Date May 08, 2002
Days to Decision 28 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