PIEZOSURGERY MEDICAL— 510(k) K083284

Substantially Equivalent

Piezosurgery S.R.L.

FDA 510(k) clearance K083284 for PIEZOSURGERY MEDICAL, Substantially Equivalent on 2009-04-08. Applicant: Piezosurgery S.R.L.. Device class: 2.

Clearance details

Applicant: Piezosurgery S.R.L.
Product code: Code JDX
Device class: Class 2
Regulation: 21 CFR 888.4580
Advisory panel: Orthopedic
Date received: 2008-11-07
Decision date: 2009-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rome, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDX

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K172464 — XD880A Ultrasonic Osteotomy Surgical System2018-04-24
K163610 — PIEZOTOME M+, PIEZOTOME M+ Handpiece2017-05-19
K153743 — PIEZOSURGERY PLUS2016-05-25
K132848 — PIEZOSURGERY FLEX2013-11-29

More clearances from Piezosurgery S.R.L.

K091227 — PIEZOSURGERY 3; OSSTEM PIEZO2009-12-29
K052518 — PIEZOSURGERY2005-11-16
K043408 — PIEZOSURGERY DEVICE2005-06-08

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