The following data is part of a premarket notification filed by Osseofuse International, Inc. with the FDA for Conical Plus Implant System.
| Device ID | K181157 |
| 510k Number | K181157 |
| Device Name: | Conical Plus Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OsseoFuse International, Inc. 5023 North Parkway Calabasas Calabasas, CA 91302 |
| Contact | Jennifer Cha |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt 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 | 2018-05-01 |
| Decision Date | 2019-05-24 |