Cleared Special

OSTEOPAL plus

K153737 · Heraeus Medical GmbH · Orthopedic
Apr 2016
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K153737 is an FDA 510(k) clearance for the OSTEOPAL plus, a Bone Cement (Class II — Special Controls, product code LOD), submitted by Heraeus Medical GmbH (Wehrheim, DE). The FDA issued a Cleared decision on April 22, 2016, 116 days after receiving the submission on December 28, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K153737 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2015
Decision Date April 22, 2016
Days to Decision 116 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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