The following data is part of a premarket notification filed by Hager & Meisinger Gmbh with the FDA for Oktagon Implant System.
| Device ID | K180360 |
| 510k Number | K180360 |
| Device Name: | OKTAGON Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Hager & Meisinger GmbH Hansemannstrasse 10 Neuss, DE 41468 |
| Contact | Adam Tomczak |
| Correspondent | Adam Tomczak Hager & Meisinger GmbH Hansemannstrasse 10 Neuss, DE 41468 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-09 |
| Decision Date | 2018-05-10 |
| Summary: | summary |