Cleared Traditional

Bone Cement Genta, Bone Cement HV, Bone Cement LV

K211163 · Tecres S.P.A. · Orthopedic
Jan 2023
Decision
630d
Days
Class 2
Risk

About This 510(k) Submission

K211163 is an FDA 510(k) clearance for the Bone Cement Genta, Bone Cement HV, Bone Cement LV, a Bone Cement (Class II — Special Controls, product code LOD), submitted by Tecres S.P.A. (Sommacampagna, IT). The FDA issued a Cleared decision on January 9, 2023, 630 days after receiving the submission on April 19, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K211163 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2021
Decision Date January 09, 2023
Days to Decision 630 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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