Cleared Traditional

Ultrasonic Osteotomy Surgical System

K201274 · Smtp Technology Co., Ltd. · Orthopedic
Feb 2021
Decision
283d
Days
Class 2
Risk

About This 510(k) Submission

K201274 is an FDA 510(k) clearance for the Ultrasonic Osteotomy Surgical System, a Instrument, Surgical, Sonic And Accessory/attachment (Class II — Special Controls, product code JDX), submitted by Smtp Technology Co., Ltd. (Zhangjiagang, CN). The FDA issued a Cleared decision on February 19, 2021, 283 days after receiving the submission on May 12, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4580.

Submission Details

510(k) Number K201274 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2020
Decision Date February 19, 2021
Days to Decision 283 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDX — Instrument, Surgical, Sonic And Accessory/attachment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.4580