Cleared Traditional

Footmotion Plating System

K161448 · Newclip Technics · Orthopedic
Oct 2016
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K161448 is an FDA 510(k) clearance for the Footmotion Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Newclip Technics (Haute-Goulaine, FR). The FDA issued a Cleared decision on October 31, 2016, 159 days after receiving the submission on May 25, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K161448 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 2016
Decision Date October 31, 2016
Days to Decision 159 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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