Cleared Traditional

Activ Ankle

K173641 · Newclip Technics · Orthopedic
Jan 2018
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K173641 is an FDA 510(k) clearance for the Activ Ankle, 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 16, 2018, 53 days after receiving the submission on November 24, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K173641 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2017
Decision Date January 16, 2018
Days to Decision 53 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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