Cleared Traditional

ZVPLASTY

K141419 · Zavation, LLC · Orthopedic
Sep 2014
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K141419 is an FDA 510(k) clearance for the ZVPLASTY, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by Zavation, LLC (Flowood, US). The FDA issued a Cleared decision on September 12, 2014, 106 days after receiving the submission on May 29, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K141419 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2014
Decision Date September 12, 2014
Days to Decision 106 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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