The following data is part of a premarket notification filed by Hanchang Co., Ltd. with the FDA for Spinekure Kyphoplasty System.
| Device ID | K172871 |
| 510k Number | K172871 |
| Device Name: | SpineKure Kyphoplasty System |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | Hanchang Co., Ltd. #301-204 Bucheon Techno-park 345, Seokcheon-ro Bucheon-si, KR 14501 |
| Contact | An Kwon Ho |
| Correspondent | Geumhyeon Kim DT&S Co., Ltd. #1206, Mario Tower 28, Digital-ro 30-gil Guro-gu, KR 08389 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-21 |
| Decision Date | 2018-05-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809300542973 | K172871 | 000 |
| 08809300542966 | K172871 | 000 |
| 08809300542959 | K172871 | 000 |
| 08809300542942 | K172871 | 000 |
| 08809300542935 | K172871 | 000 |
| 08809300542928 | K172871 | 000 |