Cleared Abbreviated

OSTEOPAL V

K050085 · Heraeus Kulzer,GmbH · Orthopedic
Sep 2005
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K050085 is an FDA 510(k) clearance for the OSTEOPAL V, a Bone Cement (Class II — Special Controls, product code LOD), submitted by Heraeus Kulzer,GmbH (Hanau, DE). The FDA issued a Cleared decision on September 14, 2005, 244 days after receiving the submission on January 13, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K050085 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2005
Decision Date September 14, 2005
Days to Decision 244 days
Submission Type Abbreviated
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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