Cleared Traditional

2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors

K150715 · Tornier, Inc. · Orthopedic
Jul 2015
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K150715 is an FDA 510(k) clearance for the 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors, 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 July 28, 2015, 131 days after receiving the submission on March 19, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K150715 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2015
Decision Date July 28, 2015
Days to Decision 131 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