The following data is part of a premarket notification filed by Shanghai Sanyou Medical Co, Ltd with the FDA for Shanghai Sanyou Carmen Cervical Fusion System.
| Device ID | K163366 |
| 510k Number | K163366 |
| Device Name: | Shanghai Sanyou CARMEN Cervical Fusion System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Shanghai Sanyou Medical Co, LTD 1988 Jiatang Road Jiading District, CN 201807 |
| Contact | David Fan |
| Correspondent | Christine Scifert MRC-X, LLC 6075 Poplar Avenue Suite 500 Memphis, TN 38119 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-30 |
| Decision Date | 2017-10-05 |
| Summary: | summary |