Cleared Traditional

Biomet Bone Cement R

K172408 · Biomet, Inc. · Orthopedic
Oct 2017
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K172408 is an FDA 510(k) clearance for the Biomet Bone Cement R, a Bone Cement (Class II — Special Controls, product code LOD), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 5, 2017, 57 days after receiving the submission on August 9, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K172408 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2017
Decision Date October 05, 2017
Days to Decision 57 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LOD — Bone Cement
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3027

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