Cleared Traditional

ForeFoot STP System

K150871 · Tornier, Inc. · Orthopedic
Aug 2015
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K150871 is an FDA 510(k) clearance for the ForeFoot STP System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Tornier, Inc. (Medina, US). The FDA issued a Cleared decision on August 4, 2015, 125 days after receiving the submission on April 1, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K150871 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2015
Decision Date August 04, 2015
Days to Decision 125 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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