The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for The Maestro System.
| Device ID | K972313 |
| 510k Number | K972313 |
| Device Name: | THE MAESTRO SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOHORIZONS IMPLANT SYSTEMS, INC. 2129 MONTGOMERY WAY Birmingham, AL 35209 |
| Contact | R. Steven Boggan |
| Correspondent | R. Steven Boggan BIOHORIZONS IMPLANT SYSTEMS, INC. 2129 MONTGOMERY WAY Birmingham, AL 35209 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-20 |
| Decision Date | 1997-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847236002275 | K972313 | 000 |
| 00847236001926 | K972313 | 000 |
| 00847236001933 | K972313 | 000 |
| 00847236002039 | K972313 | 000 |
| 00847236002046 | K972313 | 000 |
| 00847236002053 | K972313 | 000 |
| 00847236002237 | K972313 | 000 |
| 00847236002244 | K972313 | 000 |
| 00847236002251 | K972313 | 000 |
| 00847236001889 | K972313 | 000 |