Cleared Traditional

PIEZOELECTRIC SYSTEM

K100410 · Satelec · Orthopedic
Apr 2010
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K100410 is an FDA 510(k) clearance for the PIEZOELECTRIC SYSTEM, a Instrument, Surgical, Sonic And Accessory/attachment (Class II — Special Controls, product code JDX), submitted by Satelec (Mt. Laurel, US). The FDA issued a Cleared decision on April 28, 2010, 71 days after receiving the submission on February 16, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4580.

Submission Details

510(k) Number K100410 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2010
Decision Date April 28, 2010
Days to Decision 71 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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