# Tianjin Zhengtian Medical Instrument Co., Ltd.

- Location (FDA's records): Tianjin, CN
- FDA decisions: 3 (2016–2018): 3 510(k) clearances
- Product codes: HWC (1), HRS (1), NKB (1)
- 510(k) review time since 2016: median 266 days, against 109 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Changzhou Orthmed Medical Instrument Co., Ltd.: 2 (https://510kreport.com/company/changzhou-orthmed-medical-instrument)
- Osteomed LP: 1 (https://510kreport.com/company/osteomed)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Changzhou Orthmar Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/changzhou-orthmar-medical-instrument)
- Xiamen Double Engline Medical Material Co., Ltd.: 1 (https://510kreport.com/company/xiamen-double-engline-medical-material)

## Recent decisions
- K172267: IRENE Thoracolumbar Fixation System (Mar 6, 2018)
- K170056: IRENE Cannulated Screw System (Oct 23, 2017)
- K151508: IRENE Locking Compression Plate System (Feb 25, 2016)

Source page: https://510kreport.com/company/tianjin-zhengtian-medical-instrument