PIEZOTOME M+, PIEZOTOME M+ Handpiece

FDA 510(k) K163610 · Satalec-Acteon Group

Substantially Equivalent

510(k) numberK163610

Submission

Device name
PIEZOTOME M+, PIEZOTOME M+ Handpiece
Applicant
Satalec-Acteon Group
Merignac, FR
Received
December 22, 2016
Decision date
May 19, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JDX – Instrument, Surgical, Sonic And Accessory/Attachment
Device class
Class II (moderate risk)
Regulation
21 CFR 888.4580
Specialty
Orthopedic

Other 510(k)s with product code JDX

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K201274Ultrasonic Osteotomy Surgical SystemJDX · Traditional Smtp Technology Co., Ltd.02/19/2021SE
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K153743Piezosurgery PlusJDX · Traditional Mectron S.P.A.05/25/2016SE
K132848Piezosurgery FlexJDX · Traditional Mectron S.P.A.11/29/2013SE
K100410Piezoelectric SystemJDX · Traditional Satelec04/28/2010SE
K093805Oscar 3JDX · Traditional Orthosonics, Ltd.02/19/2010SE
K083284Piezosurgery MedicalJDX · Traditional Piezosurgery S.R.L.04/08/2009SE
K083830Oscar Bone ResectorJDX · Traditional Orthosonics, Ltd.03/20/2009SE
K072961Lotus Ultrasonic System for Cemented Implant Extraction (Uscix)JDX · Traditional Sra Developments, Ltd.12/19/2007SE
K051053Oscar, Model OE3000DBJDX · Traditional Orthosonics, Ltd.07/21/2005SE

Questions and answers

When was PIEZOTOME M+, PIEZOTOME M+ Handpiece cleared by the FDA?

PIEZOTOME M+, PIEZOTOME M+ Handpiece (K163610) received a 510(k) decision of Substantially Equivalent on May 19, 2017, 148 days after the submission was received.

What is the product code of K163610?

The FDA product code is JDX – Instrument, Surgical, Sonic And Accessory/Attachment, a Class II (moderate risk) device regulated under 21 CFR 888.4580.