Cleared Traditional

Alians Elbow Locking Plating System

K152289 · Newclip Technics · Orthopedic
Aug 2016
Decision
370d
Days
Class 2
Risk

About This 510(k) Submission

K152289 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 August 17, 2016, 370 days after receiving the submission on August 13, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K152289 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2015
Decision Date August 17, 2016
Days to Decision 370 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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