PIEZOTOME M+, PIEZOTOME M+ Handpiece— 510(k) K163610

Name: FDA 510(k) clearance K163610
Creator: U.S. Food and Drug Administration
Published: 2017-05-19

Substantially Equivalent

Satalec-Acteon Group

FDA 510(k) clearance K163610 for PIEZOTOME M+, PIEZOTOME M+ Handpiece, Substantially Equivalent on 2017-05-19. Applicant: Satalec-Acteon Group. Device class: 2.

Clearance details

Applicant: Satalec-Acteon Group
Product code: Code JDX
Device class: Class 2
Regulation: 21 CFR 888.4580
Advisory panel: Orthopedic
Date received: 2016-12-22
Decision date: 2017-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Merignac, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDX

view all

K201274 — Ultrasonic Osteotomy Surgical System2021-02-19
K172464 — XD880A Ultrasonic Osteotomy Surgical System2018-04-24
K153743 — PIEZOSURGERY PLUS2016-05-25
K132848 — PIEZOSURGERY FLEX2013-11-29
K100410 — PIEZOELECTRIC SYSTEM2010-04-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.