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FDA 510(k)

Ultrasonic Osteotomy Surgical System

K-Number: K201274 · 2021-02-19

ApplicantSmtp Technology Co., Ltd.
Decision Date2021-02-19
Product CodeJDX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ultrasonic Osteotomy Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Smtp Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K201274. The device is classified under product code JDX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultrasonic Osteotomy Surgical System?

Ultrasonic Osteotomy Surgical System is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Smtp Technology Co., Ltd.. The 510(k) number is K201274.

When did Ultrasonic Osteotomy Surgical System receive FDA 510(k) clearance?

Ultrasonic Osteotomy Surgical System received FDA 510(k) clearance on 2021-02-19, under 510(k) number K201274.

Who is the listed applicant for Ultrasonic Osteotomy Surgical System?

The FDA 510(k) record lists Smtp Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultrasonic Osteotomy Surgical System?

The FDA product code for Ultrasonic Osteotomy Surgical System is JDX.

Other records listing Smtp Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212750Ultrasonic Surgical Aspirator System, Model: XD880BK202299Ultrasonic Surgical Aspirator System

Related Devices (Code: JDX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research ConsortiumK163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon GroupK153743PIEZOSURGERY PLUSMectron S.P.A.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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