The following data is part of a premarket notification filed by Tianjin Zhengtian Medical Instrument Co., Ltd with the FDA for Irene Cannulated Screw System.
| Device ID | K170056 |
| 510k Number | K170056 |
| Device Name: | IRENE Cannulated Screw System |
| Classification | Screw, Fixation, Bone |
| Applicant | TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD NO.318, JINGYI ROAD, AIRPORT ECONOMIC ZONE Tianjin, CN 100082 |
| Contact | Wang Qi |
| Correspondent | Wang Qi TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD NO.318, JINGYI ROAD, AIRPORT ECONOMIC ZONE Tianjin, CN 100082 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-06 |
| Decision Date | 2017-10-23 |
| Summary: | summary |