The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Modification To The Maestro System.
| Device ID | K030463 |
| 510k Number | K030463 |
| Device Name: | MODIFICATION TO THE MAESTRO SYSTEM |
| 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 | 2003-02-12 |
| Decision Date | 2003-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847236001896 | K030463 | 000 |
| 00847236000035 | K030463 | 000 |
| 00847236000066 | K030463 | 000 |
| 00847236000080 | K030463 | 000 |
| 00847236000103 | K030463 | 000 |
| 00847236000127 | K030463 | 000 |
| 00847236000158 | K030463 | 000 |
| 00847236000165 | K030463 | 000 |
| 00847236000172 | K030463 | 000 |
| 00847236000189 | K030463 | 000 |
| 00847236000196 | K030463 | 000 |
| 00847236001865 | K030463 | 000 |
| 00847236001872 | K030463 | 000 |
| 00847236000011 | K030463 | 000 |