Cleared Traditional

TORNIER, PITON FIXATION IMPLANT SYSTEM

K091870 · Tornier · Orthopedic
Sep 2009
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K091870 is an FDA 510(k) clearance for the TORNIER, PITON FIXATION IMPLANT SYSTEM, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Tornier (Beverly, US). The FDA issued a Cleared decision on September 21, 2009, 90 days after receiving the submission on June 23, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K091870 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2009
Decision Date September 21, 2009
Days to Decision 90 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