Cleared Traditional

Refobacin Bone Cement R

K171540 · Biomet, Inc. · Orthopedic
Aug 2017
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K171540 is an FDA 510(k) clearance for the Refobacin 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 August 30, 2017, 96 days after receiving the submission on May 26, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K171540 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2017
Decision Date August 30, 2017
Days to Decision 96 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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