Cleared Traditional

KYPHON VuE Bone Cement

K220131 · Tecres S.P.A. · Orthopedic
Apr 2022
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K220131 is an FDA 510(k) clearance for the KYPHON VuE Bone Cement, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by Tecres S.P.A. (Sommacampagna, IT). The FDA issued a Cleared decision on April 18, 2022, 90 days after receiving the submission on January 18, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K220131 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2022
Decision Date April 18, 2022
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code NDN — Cement, Bone, Vertebroplasty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3027

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