The following data is part of a premarket notification filed by Anthogyr Sas with the FDA for Axiom Px.
| Device ID | K161177 |
| 510k Number | K161177 |
| Device Name: | Axiom PX |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ANTHOGYR SAS 2237 AVENUE ANDRE LASQUIN Sallanches, FR 74700 |
| Contact | Therese Candau |
| Correspondent | Therese Candau ANTHOGYR SAS 2237 AVENUE ANDRE LASQUIN Sallanches, FR 74700 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-26 |
| Decision Date | 2017-06-15 |
| Summary: | summary |