Cleared Traditional

PIEZOSURGERY PLUS

K153743 · Mectron S.P.A. · Orthopedic
May 2016
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K153743 is an FDA 510(k) clearance for the PIEZOSURGERY PLUS, a Instrument, Surgical, Sonic And Accessory/attachment (Class II — Special Controls, product code JDX), submitted by Mectron S.P.A. (Carasco, IT). The FDA issued a Cleared decision on May 25, 2016, 149 days after receiving the submission on December 28, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4580.

Submission Details

510(k) Number K153743 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2015
Decision Date May 25, 2016
Days to Decision 149 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDX — Instrument, Surgical, Sonic And Accessory/attachment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.4580

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