The following data is part of a premarket notification filed by Shanghai Sanyou Medical Co, Ltd with the FDA for Shanghai Sanyou Peek Cage System.
| Device ID | K163422 |
| 510k Number | K163422 |
| Device Name: | Shanghai Sanyou PEEK Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | SHANGHAI SANYOU MEDICAL CO, LTD 1988 JIATANG ROAD Jiadiang District, CN 201807 |
| Contact | David Fan |
| Correspondent | Christine Scifert MRC/X, LLC 6075 Poplar Avenue, Suite 500 Memphis, TN 38119 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-06 |
| Decision Date | 2017-09-18 |
| Summary: | summary |