The following data is part of a premarket notification filed by Trauson (jiangsu) Medical Instrument Co., Ltd. with the FDA for Trauson Bone Plate.
| Device ID | K073432 |
| 510k Number | K073432 |
| Device Name: | TRAUSON BONE PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. LANE 999, ZHONGSHAN NO. 2 ROAD SUITE 8D, NO. 19 Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. LANE 999, ZHONGSHAN NO. 2 ROAD SUITE 8D, NO. 19 Shanghai, CN 200030 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-06 |
| Decision Date | 2008-08-13 |
| Summary: | summary |