Cleared Traditional

PIEZOSURGERY FLEX

K132848 · Mectron S.P.A. · Orthopedic
Nov 2013
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K132848 is an FDA 510(k) clearance for the PIEZOSURGERY FLEX, a Instrument, Surgical, Sonic And Accessory/attachment (Class II — Special Controls, product code JDX), submitted by Mectron S.P.A. (Rome, IT). The FDA issued a Cleared decision on November 29, 2013, 79 days after receiving the submission on September 11, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4580.

Submission Details

510(k) Number K132848 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2013
Decision Date November 29, 2013
Days to Decision 79 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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