The following data is part of a premarket notification filed by Suzhou Gemmed Medical Instrument Co., Ltd. with the FDA for Gemmed Pedicle Screw Spinal System.
| Device ID | K151592 |
| 510k Number | K151592 |
| Device Name: | Gemmed Pedicle Screw Spinal System |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SUZHOU GEMMED MEDICAL INSTRUMENT CO., LTD. A22 &26, Science & Technology Development Zone, Jinnan Rd., Jinfeng Town Zhangjiagang City, CN 215625 |
| Contact | Xue Fang Zhou |
| Correspondent | Alice Gong Shanghai Yarui Consultant Co., Ltd 503 Room, 8 Building, 600 Liu Zhou Road Shanghai, CN 200233 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-12 |
| Decision Date | 2015-09-24 |
| Summary: | summary |