Cleared Traditional

Footmotion Plating System

K221395 · Newclip Technics · Orthopedic
Jul 2022
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K221395 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 July 1, 2022, 49 days after receiving the submission on May 13, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K221395 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2022
Decision Date July 01, 2022
Days to Decision 49 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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