The following data is part of a premarket notification filed by Hung Chun Bio-s Co., Ltd. with the FDA for Hc Spinal System.
| Device ID | K151362 |
| 510k Number | K151362 |
| Device Name: | HC Spinal System |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | HUNG CHUN BIO-S CO., LTD. NO.12, LUKE 1ST RD., LUZHU DIST., Kaohsiung City, TW 821 |
| Contact | Hsin Tai Hu |
| Correspondent | Michael Lee ACMEBIOTECHS CONSULTING INCORPORATION 38F-7, NO.368, SEC. 1, WENHUA RD., BANQIAO DIST., New Taipei City, TW 22041 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-21 |
| Decision Date | 2016-05-05 |
| Summary: | summary |