The following data is part of a premarket notification filed by Dio Medical Co., Ltd. with the FDA for Huvex Interspinous Fixation System.
| Device ID | K162849 |
| 510k Number | K162849 |
| Device Name: | Huvex Interspinous Fixation System |
| Classification | Spinous Process Plate |
| Applicant | DIO MEDICAL CO., LTD. 101-105 MEGACENTER, SK TECHNOPARK 190-1 SANGDAWON-DONG Jungwon-gu Sungnam-si, KR 462-850 |
| Contact | Lee Sung-hee |
| Correspondent | Jaewon Jang DIO MEDICAL CORPORATION 8770 West Bryn Mawr Avenue, Suite 1250 Chicago, IL 60631 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-11 |
| Decision Date | 2017-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800039820585 | K162849 | 000 |
| 08800039820578 | K162849 | 000 |
| 08800039820561 | K162849 | 000 |
| 08800039820554 | K162849 | 000 |
| 08800039820547 | K162849 | 000 |
| 08800039820530 | K162849 | 000 |
| 08800113935563 | K162849 | 000 |