Cleared Traditional

A. L. P. S. Clavicle Plating System

K173767 · Biomet, Inc. · Orthopedic
Apr 2018
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K173767 is an FDA 510(k) clearance for the A. L. P. S. Clavicle Plating System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 6, 2018, 116 days after receiving the submission on December 11, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K173767 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2017
Decision Date April 06, 2018
Days to Decision 116 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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