The following data is part of a premarket notification filed by Smtp Technology Co., Ltd with the FDA for Ultrasonic Osteotomy Surgical System.
| Device ID | K201274 |
| 510k Number | K201274 |
| Device Name: | Ultrasonic Osteotomy Surgical System |
| Classification | Instrument, Surgical, Sonic And Accessory/attachment |
| Applicant | SMTP Technology Co., Ltd 1F&4F, Building A, Emerging Industry Incubation Center Zhangjiagang, CN 215634 |
| Contact | Songtao Zhan |
| Correspondent | Songtao Zhan SMTP Technology Co., Ltd 1F&4F, Building A, Emerging Industry Incubation Center Zhangjiagang, CN 215634 |
| Product Code | JDX |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-12 |
| Decision Date | 2021-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972603519200 | K201274 | 000 |
| 06972603519071 | K201274 | 000 |
| 06972603519057 | K201274 | 000 |
| 06972603519040 | K201274 | 000 |
| 06972603519033 | K201274 | 000 |
| 06972603519026 | K201274 | 000 |
| 06972603519019 | K201274 | 000 |
| 06972603519002 | K201274 | 000 |
| 06927292311475 | K201274 | 000 |
| 06972603519064 | K201274 | 000 |
| 06972603519088 | K201274 | 000 |
| 06972603519095 | K201274 | 000 |
| 06972603519101 | K201274 | 000 |
| 06972603519194 | K201274 | 000 |
| 06972603519187 | K201274 | 000 |
| 06972603519170 | K201274 | 000 |
| 06972603519163 | K201274 | 000 |
| 06972603519156 | K201274 | 000 |
| 06972603519149 | K201274 | 000 |
| 06972603519132 | K201274 | 000 |
| 06972603519125 | K201274 | 000 |
| 06972603519118 | K201274 | 000 |
| 06972603519217 | K201274 | 000 |