Cleared Traditional

Activ Ankle Locking Plating System

K143061 · Newclip Technics · Orthopedic
Jan 2015
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K143061 is an FDA 510(k) clearance for the Activ Ankle Locking 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 January 26, 2015, 94 days after receiving the submission on October 24, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K143061 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2014
Decision Date January 26, 2015
Days to Decision 94 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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