Cleared Special

PALACOS R pro

K150119 · Heraeus Medical GmbH · Orthopedic
Jun 2015
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K150119 is an FDA 510(k) clearance for the PALACOS R 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 June 17, 2015, 148 days after receiving the submission on January 20, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K150119 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2015
Decision Date June 17, 2015
Days to Decision 148 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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