The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Maximus 3.0 And Os Implants.
| Device ID | K052419 |
| 510k Number | K052419 |
| Device Name: | MAXIMUS 3.0 AND OS IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham, AL 35243 |
| Contact | Winston Greer |
| Correspondent | Winston Greer BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham, AL 35243 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-02 |
| Decision Date | 2005-09-20 |
| Summary: | summary |