Cleared Special

SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75

K111399 · Arthrocare Corp. · Orthopedic
Jul 2011
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K111399 is an FDA 510(k) clearance for the SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75, 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 July 20, 2011, 62 days after receiving the submission on May 19, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K111399 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2011
Decision Date July 20, 2011
Days to Decision 62 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

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