Cleared Traditional

PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G

K202475 · Heraeus Medical GmbH · Orthopedic
Nov 2020
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K202475 is an FDA 510(k) clearance for the PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+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 November 23, 2020, 87 days after receiving the submission on August 28, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K202475 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2020
Decision Date November 23, 2020
Days to Decision 87 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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