Cleared Special

PALACOS R+G PRO

K142157 · Heraeus Medical GmbH · Orthopedic
Sep 2014
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K142157 is an FDA 510(k) clearance for the PALACOS R+G PRO, a Bone Cement (Class II — Special Controls, product code LOD), submitted by Heraeus Medical GmbH (Wehrheim, DE). The FDA issued a Cleared decision on September 5, 2014, 30 days after receiving the submission on August 6, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K142157 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2014
Decision Date September 05, 2014
Days to Decision 30 days
Submission Type Special
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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