Cleared Traditional

PALACOS MV pro

K213812 · Heraeus Medical GmbH · Orthopedic
Feb 2022
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K213812 is an FDA 510(k) clearance for the PALACOS MV 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 February 2, 2022, 57 days after receiving the submission on December 7, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K213812 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2021
Decision Date February 02, 2022
Days to Decision 57 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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