Cleared Traditional

PALACOS fast R+G

K190766 · Heraeus Medical GmbH · Orthopedic
May 2019
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K190766 is an FDA 510(k) clearance for the PALACOS fast R+G, a Bone Cement (Class II — Special Controls, product code LOD), submitted by Heraeus Medical GmbH (Wehrheim, DE). The FDA issued a Cleared decision on May 31, 2019, 67 days after receiving the submission on March 25, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K190766 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2019
Decision Date May 31, 2019
Days to Decision 67 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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