Cleared Traditional

G3A 40 Bone Cement

K181282 · G21, S.R.L. · Orthopedic
Jan 2019
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K181282 is an FDA 510(k) clearance for the G3A 40 Bone Cement, a Bone Cement (Class II — Special Controls, product code LOD), submitted by G21, S.R.L. (San Possidomio, IT). The FDA issued a Cleared decision on January 9, 2019, 239 days after receiving the submission on May 15, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K181282 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2018
Decision Date January 09, 2019
Days to Decision 239 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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