Cleared Traditional

Hi-Fatigue G Bone Cement

K192379 · Osartis GmbH · Orthopedic
Nov 2019
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K192379 is an FDA 510(k) clearance for the Hi-Fatigue G Bone Cement, a Bone Cement (Class II — Special Controls, product code LOD), submitted by Osartis GmbH (Dieburg, DE). The FDA issued a Cleared decision on November 27, 2019, 89 days after receiving the submission on August 30, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K192379 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2019
Decision Date November 27, 2019
Days to Decision 89 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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