Cleared Traditional

OSTEOPAL? V

K241674 · Heraeus Medical GmbH · Orthopedic
Dec 2024
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K241674 is an FDA 510(k) clearance for the OSTEOPAL? V, a Bone Cement (Class II — Special Controls, product code LOD), submitted by Heraeus Medical GmbH (Wehrheim, DE). The FDA issued a Cleared decision on December 5, 2024, 177 days after receiving the submission on June 11, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K241674 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 2024
Decision Date December 05, 2024
Days to Decision 177 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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