Cleared Traditional

OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES

K083240 · Arthrocare Corp. · Orthopedic
Jan 2009
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K083240 is an FDA 510(k) clearance for the OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES, 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 January 12, 2009, 70 days after receiving the submission on November 3, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K083240 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2008
Decision Date January 12, 2009
Days to Decision 70 days
Submission Type Traditional
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

More from Arthrocare Corp.

View all
Adjustable Fixation Device
K153186 · MBI · Jan 2016
SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT
K131709 · LRC · Oct 2013
SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR
K130196 · MBI · Feb 2013
SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75
K111399 · MBI · Jul 2011
TITAN TI SUTURE ANCHOR SYSTEM
K111397 · MBI · Jul 2011