The following data is part of a premarket notification filed by Jiangsu Ideal Medical Science & Technology Co., Ltd. with the FDA for Ideal Pedicle Screw Spinal System.
| Device ID | K142957 |
| 510k Number | K142957 |
| Device Name: | Ideal Pedicle Screw Spinal System |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LTD. East Area, Jinfeng Industry Park Zhangjiagang, CN 215625 |
| Contact | Wei Li |
| Correspondent | Alice Gong JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LTD. 503 Room, 8 Building, 600 Liu Zhou Road Shanghai, CN 200233 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-14 |
| Decision Date | 2015-01-30 |
| Summary: | summary |