Cleared Traditional

Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve

K212431 · Biomet, Inc. · Orthopedic
Feb 2022
Decision
187d
Days
Class 2
Risk

About This 510(k) Submission

K212431 is an FDA 510(k) clearance for the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve, 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 February 7, 2022, 187 days after receiving the submission on August 4, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K212431 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2021
Decision Date February 07, 2022
Days to Decision 187 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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