The following data is part of a premarket notification filed by Double Medical Technology Inc with the FDA for Double Medical Cage System.
| Device ID | K172828 |
| 510k Number | K172828 |
| Device Name: | Double Medical Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Double Medical Technology Inc No. 18 Shanbianhong East Road, Haicang District Xiamen, CN 361026 |
| Contact | Yan Zuo |
| Correspondent | Yan Zuo Double Medical Technology Inc No. 18 Shanbianhong East Road, Haicang District Xiamen, CN 361026 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2018-02-01 |
| Summary: | summary |