Cleared Traditional

TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR

K133777 · Tornier, Inc. · Orthopedic
Apr 2014
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K133777 is an FDA 510(k) clearance for the TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on April 4, 2014, 113 days after receiving the submission on December 12, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K133777 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2013
Decision Date April 04, 2014
Days to Decision 113 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