Cleared Special

A.L.P.S. Clavicle Plating System

K210192 · Biomet, Inc. · Orthopedic
Feb 2021
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K210192 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 February 19, 2021, 25 days after receiving the submission on January 25, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K210192 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2021
Decision Date February 19, 2021
Days to Decision 25 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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