Cleared Special

SPEEDFIX SUTURE SYSTEM

K101437 · Arthrocare Corp. · Orthopedic
Oct 2010
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K101437 is an FDA 510(k) clearance for the SPEEDFIX SUTURE 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 October 29, 2010, 158 days after receiving the submission on May 24, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K101437 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2010
Decision Date October 29, 2010
Days to Decision 158 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