K201274 is an FDA 510(k) clearance for the Ultrasonic Osteotomy Surgical System. This device is classified as 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 FDA review panel. Regulated under 21 CFR 888.4580.
| 510(k) Number | K201274 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | JDX - Instrument, Surgical, Sonic And Accessory/attachment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.4580 |