The following data is part of a premarket notification filed by Tianjin Zhengtian Medical Instrument Co.,ltd. with the FDA for Irene Thoracolumbar Fixation System.
| Device ID | K172267 |
| 510k Number | K172267 |
| Device Name: | IRENE Thoracolumbar Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Tianjin Zhengtian Medical Instrument Co.,Ltd. No. 318, Jingyi Road, Airport Economic Zone Tianjin, CN 300308 |
| Contact | Ou Changli |
| Correspondent | Changli Ou Tianjin Zhengtian Medical Instrument Co.,Ltd. No. 318, Jingyi Road, Airport Economic Zone Tianjin, CN 300308 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-27 |
| Decision Date | 2018-03-06 |
| Summary: | summary |