The following data is part of a premarket notification filed by Double Medical Technology Inc with the FDA for Double Medical Universal Spine System.
| Device ID | K151458 |
| 510k Number | K151458 |
| Device Name: | Double Medical Universal Spine System |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | Double Medical Technology Inc No. 18 Shanbianhong East Road, Haicang District Xiamen, CN 361022 |
| Contact | Da Zeng |
| Correspondent | Da Zeng Double Medical Technology Inc No. 18 Shanbianhong East Road, Haicang District Xiamen, CN 361026 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-01 |
| Decision Date | 2016-08-22 |
| Summary: | summary |