Cleared Special

SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR

K130196 · Arthrocare Corp. · Orthopedic
Feb 2013
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K130196 is an FDA 510(k) clearance for the SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Arthrocare Corp. (Austin, US). The FDA issued a Cleared decision on February 27, 2013, 30 days after receiving the submission on January 28, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K130196 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2013
Decision Date February 27, 2013
Days to Decision 30 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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