Cleared Special

MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS

K030383 · Depuyacromed · Orthopedic
Feb 2003
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K030383 is an FDA 510(k) clearance for the MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on February 26, 2003, 21 days after receiving the submission on February 5, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K030383 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2003
Decision Date February 26, 2003
Days to Decision 21 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