Cleared Special

TITAN TI SUTURE ANCHOR SYSTEM

K111397 · Arthrocare Corp. · Orthopedic
Jul 2011
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K111397 is an FDA 510(k) clearance for the TITAN TI SUTURE ANCHOR SYSTEM, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Arthrocare Corp. (Sunnyvale, US). The FDA issued a Cleared decision on July 12, 2011, 54 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 K111397 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2011
Decision Date July 12, 2011
Days to Decision 54 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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