The following data is part of a premarket notification filed by Innobiosurg Co., Ltd. with the FDA for Ibs System.
| Device ID | K220517 |
| 510k Number | K220517 |
| Device Name: | IBS System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu Daejeon, KR 34027 |
| Contact | Ga Yun Kim |
| 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 | 2022-02-23 |
| Decision Date | 2022-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800090661271 | K220517 | 000 |
| 08800039370288 | K220517 | 000 |
| 08800039368933 | K220517 | 000 |
| 08800039365178 | K220517 | 000 |
| 08800039363358 | K220517 | 000 |
| 08800039363341 | K220517 | 000 |
| 08800039363334 | K220517 | 000 |
| 08800039363327 | K220517 | 000 |
| 08800039363310 | K220517 | 000 |
| 08800039363303 | K220517 | 000 |
| 08800039363297 | K220517 | 000 |
| 08800039363280 | K220517 | 000 |
| 08800039363273 | K220517 | 000 |
| 08800039370301 | K220517 | 000 |
| 08800039370332 | K220517 | 000 |
| 08800039370356 | K220517 | 000 |
| 08800090661264 | K220517 | 000 |
| 08800090661257 | K220517 | 000 |
| 08800090661240 | K220517 | 000 |
| 08800090661134 | K220517 | 000 |
| 08800090661127 | K220517 | 000 |
| 08800090661110 | K220517 | 000 |
| 08800090661103 | K220517 | 000 |
| 08800090661097 | K220517 | 000 |
| 08800039393584 | K220517 | 000 |
| 08800039393577 | K220517 | 000 |
| 08800039370608 | K220517 | 000 |
| 08800039370585 | K220517 | 000 |
| 08800039363266 | K220517 | 000 |