The following data is part of a premarket notification filed by Innobiosurg Co., Ltd. with the FDA for Magicore Ii System.
| Device ID | K192197 |
| 510k Number | K192197 |
| Device Name: | Magicore II System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu Daejeon, KR 34027 |
| Contact | Eun-ji Yoo |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-13 |
| Decision Date | 2020-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800090601611 | K192197 | 000 |
| 08800039397025 | K192197 | 000 |
| 08800039396981 | K192197 | 000 |
| 08800039380188 | K192197 | 000 |
| 08800039371711 | K192197 | 000 |
| 08800039371650 | K192197 | 000 |
| 08800039371643 | K192197 | 000 |
| 08800090661332 | K192197 | 000 |
| 08800090661219 | K192197 | 000 |
| 08800090661165 | K192197 | 000 |
| 08800039397063 | K192197 | 000 |
| 08800039399319 | K192197 | 000 |
| 08800039399326 | K192197 | 000 |
| 08800090600034 | K192197 | 000 |
| 08800090600027 | K192197 | 000 |
| 08800039399395 | K192197 | 000 |
| 08800039399388 | K192197 | 000 |
| 08800039399371 | K192197 | 000 |
| 08800039399364 | K192197 | 000 |
| 08800039399357 | K192197 | 000 |
| 08800039399340 | K192197 | 000 |
| 08800039399333 | K192197 | 000 |
| 08800177388879 | K192197 | 000 |