The following data is part of a premarket notification filed by Huvexel Co., Ltd with the FDA for Faset Fixation System.
| Device ID | K180729 |
| 510k Number | K180729 |
| Device Name: | FaSet Fixation System |
| Classification | System, Facet Screw Spinal Device |
| Applicant | Huvexel Co., Ltd 101-105 Megacenter, SKn Technopark, 124, Sagimakgol-ro Jungwon-gu Seongnam-si, KR 13207 |
| Contact | Sung Hee-lee |
| Correspondent | Milan George Dio Medical Corporation 8770 West Bryn Mawr Avenue, Suite 1250 Chicago, IL 60631 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-20 |
| Decision Date | 2018-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800039825306 | K180729 | 000 |
| 08800113952379 | K180729 | 000 |
| 08800113952362 | K180729 | 000 |
| 08800113952355 | K180729 | 000 |
| 08800113952348 | K180729 | 000 |
| 08800113952331 | K180729 | 000 |
| 08800113952324 | K180729 | 000 |
| 08800113952317 | K180729 | 000 |
| 08800113952300 | K180729 | 000 |
| 08800113952294 | K180729 | 000 |
| 08800113952287 | K180729 | 000 |
| 08800113952270 | K180729 | 000 |
| 08800039825290 | K180729 | 000 |
| 08800039825443 | K180729 | 000 |
| 08800039825436 | K180729 | 000 |
| 08800039825429 | K180729 | 000 |
| 08800039825412 | K180729 | 000 |
| 08800039825405 | K180729 | 000 |
| 08800113952386 | K180729 | 000 |
| 08800113952393 | K180729 | 000 |
| 08800039821735 | K180729 | 000 |
| 08800039821728 | K180729 | 000 |
| 08800039825375 | K180729 | 000 |
| 08800039825368 | K180729 | 000 |
| 08800113952522 | K180729 | 000 |
| 08800113952515 | K180729 | 000 |
| 08800113952508 | K180729 | 000 |
| 08800113952492 | K180729 | 000 |
| 08800113952485 | K180729 | 000 |
| 08800113952478 | K180729 | 000 |
| 08800113952461 | K180729 | 000 |
| 08800113952454 | K180729 | 000 |
| 08800113952447 | K180729 | 000 |
| 08800113952430 | K180729 | 000 |
| 08800113952423 | K180729 | 000 |
| 08800113952416 | K180729 | 000 |
| 08800113952409 | K180729 | 000 |
| 08800039820356 | K180729 | 000 |