Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Smtp Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-19 under approval 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. It is manufactured by Smtp Technology Co., Ltd.. The 510(k) number is K201274.

When was Ultrasonic Osteotomy Surgical System approved by the FDA?

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

What company makes Ultrasonic Osteotomy Surgical System?

Ultrasonic Osteotomy Surgical System is manufactured by Smtp Technology Co., Ltd..

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

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

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT07202312 Ozone-therapy in Non-surgical Periodontal Therapy COMPLETED NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Smtp Technology Co., Ltd.

K212750Ultrasonic Surgical Aspirator System, Model: XD880B K202299Ultrasonic Surgical Aspirator System

Related Devices (Code: JDX)

K153743PIEZOSURGERY PLUSMectron S.P.A. K163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon Group K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium

Official Source

View on FDA Database →

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

↑