The following data is part of a premarket notification filed by Trauson (jiangsu) Medical Instrument Co., Ltd. with the FDA for Trauson Bone Screw, Models Ha 3.5 And 4.5.
| Device ID | K073159 |
| 510k Number | K073159 |
| Device Name: | TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5 |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-08 |
| Decision Date | 2008-07-23 |
| Summary: | summary |