Cleared Traditional

Distal Centralizers

K193546 · Biomet, Inc. · Orthopedic
Sep 2020
Decision
280d
Days
Class 2
Risk

About This 510(k) Submission

K193546 is an FDA 510(k) clearance for the Distal Centralizers, a Prosthesis, Hip, Femoral Component, Cemented, Metal (Class II — Special Controls, product code JDG), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 25, 2020, 280 days after receiving the submission on December 20, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K193546 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2019
Decision Date September 25, 2020
Days to Decision 280 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDG — Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3360

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