Cleared Traditional

G3 40 Radiopaque Bone Cement

K193061 · G21, S.R.L. · Orthopedic
Mar 2020
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K193061 is an FDA 510(k) clearance for the G3 40 Radiopaque Bone Cement, a Bone Cement (Class II — Special Controls, product code LOD), submitted by G21, S.R.L. (San Possidonio, IT). The FDA issued a Cleared decision on March 19, 2020, 139 days after receiving the submission on November 1, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K193061 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2019
Decision Date March 19, 2020
Days to Decision 139 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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