Cleared Traditional

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

K210607 · Heraeus Medical GmbH · Orthopedic
Jul 2021
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K210607 is an FDA 510(k) clearance for the PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro, a Bone Cement (Class II — Special Controls, product code LOD), submitted by Heraeus Medical GmbH (Wehrheim, DE). The FDA issued a Cleared decision on July 9, 2021, 130 days after receiving the submission on March 1, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K210607 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2021
Decision Date July 09, 2021
Days to Decision 130 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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