The following data is part of a premarket notification filed by Tianjin Zhengtian Medical Instrument Co., Ltd with the FDA for Irene Locking Compression Plate System.
| Device ID | K151508 |
| 510k Number | K151508 |
| Device Name: | IRENE Locking Compression Plate System |
| Classification | Plate, Fixation, Bone |
| Applicant | TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD NO.318, JINGYI ROAD, AIRPORT ECONOMIC ZONE Tianjin, CN 300308 |
| Contact | Yifan Fu |
| Correspondent | Yifan Fu TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD NO.318, JINGYI ROAD, AIRPORT ECONOMIC ZONE Tianjin, CN 300308 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-04 |
| Decision Date | 2016-02-25 |
| Summary: | summary |