The following data is part of a premarket notification filed by Innobiosurg Co., Ltd. with the FDA for Ibs Implant System.
| Device ID | K202479 |
| 510k Number | K202479 |
| Device Name: | IBS Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu Daejeon, KR 34027 |
| Contact | Bo-yeon Lim |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-28 |
| Decision Date | 2020-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800039315791 | K202479 | 000 |
| 08800090662568 | K202479 | 000 |
| 08800039379373 | K202479 | 000 |
| 08800039379366 | K202479 | 000 |
| 08800039379359 | K202479 | 000 |
| 08800039379342 | K202479 | 000 |