Ultrasonic Osteotomy Surgical System— 510(k) K201274

Name: FDA 510(k) clearance K201274
Creator: U.S. Food and Drug Administration
Published: 2021-02-19

Substantially Equivalent

Smtp Technology Co., Ltd.

FDA 510(k) clearance K201274 for Ultrasonic Osteotomy Surgical System, Substantially Equivalent on 2021-02-19. Applicant: Smtp Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Smtp Technology Co., Ltd.
Product code: Code JDX
Device class: Class 2
Regulation: 21 CFR 888.4580
Advisory panel: Orthopedic
Date received: 2020-05-12
Decision date: 2021-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhangjiagang, CN

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
K100410 — PIEZOELECTRIC SYSTEM2010-04-28

More clearances from Smtp Technology Co., Ltd.

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K212750 — Ultrasonic Surgical Aspirator System, Model: XD880B2021-09-27
K202299 — Ultrasonic Surgical Aspirator System2021-05-21

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