Cleared Traditional

PALAMED G

K050855 · Heraeus Kulzer,GmbH · Orthopedic
Jul 2005
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K050855 is an FDA 510(k) clearance for the PALAMED G, a Bone Cement (Class II — Special Controls, product code LOD), submitted by Heraeus Kulzer,GmbH (Wehrheim, DE). The FDA issued a Cleared decision on July 7, 2005, 94 days after receiving the submission on April 4, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K050855 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2005
Decision Date July 07, 2005
Days to Decision 94 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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