Cleared Special

Alians Elbow Locking Plating System

K171372 · Newclip Technics · Orthopedic
Jan 2018
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K171372 is an FDA 510(k) clearance for the Alians Elbow 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 4, 2018, 239 days after receiving the submission on May 10, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K171372 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2017
Decision Date January 04, 2018
Days to Decision 239 days
Submission Type Special
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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