The following data is part of a premarket notification filed by Dragon Crown Medical Co., Ltd. with the FDA for Dcm Kyphoplasty System.
| Device ID | K162283 |
| 510k Number | K162283 |
| Device Name: | DCM Kyphoplasty System |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | Dragon Crown Medical Co., Ltd. 6F, Kehui Building, No. 109, Shunhua Road High-Tech Development Zone Jinan, CN 250101 |
| Contact | Zhi Yong Song |
| Correspondent | Zhi Yong Song Dragon Crown Medical Co., Ltd. 6F, Kehui Building, No. 109, Shunhua Road High-Tech Development Zone Jinan, CN 250101 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-15 |
| Decision Date | 2017-02-06 |
| Summary: | summary |