Cleared Special

MAGNUM MP FIXATION DEVICE

K091503 · Arthrocare Corp. · Orthopedic
Jun 2009
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K091503 is an FDA 510(k) clearance for the MAGNUM MP FIXATION DEVICE, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Arthrocare Corp. (Irvine, US). The FDA issued a Cleared decision on June 17, 2009, 27 days after receiving the submission on May 21, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K091503 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2009
Decision Date June 17, 2009
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040