The following data is part of a premarket notification filed by Trauson (jiangsu) Medical Instrument Co., Ltd. with the FDA for Trauson General Spinal System (gss).
| Device ID | K082617 |
| 510k Number | K082617 |
| Device Name: | TRAUSON GENERAL SPINAL SYSTEM (GSS) |
| Classification | Orthosis, Spinal Pedicle Fixation |
| 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 | MNI |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-09 |
| Decision Date | 2009-01-15 |
| Summary: | summary |