The following data is part of a premarket notification filed by Innobiosurg Co., Ltd. with the FDA for Ibs Implant System Ii.
| Device ID | K162099 |
| 510k Number | K162099 |
| Device Name: | IBS Implant System II |
| Classification | Implant, Endosseous, Root-form |
| Applicant | InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu Daejeon, KR 305-510 |
| Contact | Bo-reum Yoo |
| Correspondent | April Lee WithUS Group Inc 2531 Pepperdale Drive Rowland Heights, CA 91748 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-29 |
| Decision Date | 2017-02-15 |
| Summary: | summary |