Cleared Traditional

SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR

K100159 · Smith & Nephew Inc., Endoscopy Div. · Orthopedic
Apr 2010
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K100159 is an FDA 510(k) clearance for the SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Smith & Nephew Inc., Endoscopy Div. (Andover, US). The FDA issued a Cleared decision on April 19, 2010, 89 days after receiving the submission on January 20, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K100159 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2010
Decision Date April 19, 2010
Days to Decision 89 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