The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Biohorizons Tapered Internal Plus Implants.
| Device ID | K121787 |
| 510k Number | K121787 |
| Device Name: | BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOHORIZONS IMPLANT SYSTEMS, INC. 2300 RIVERCHASE CENTER Birmingham, AL 35244 |
| Contact | Michael Davis |
| Correspondent | Michael Davis BIOHORIZONS IMPLANT SYSTEMS, INC. 2300 RIVERCHASE CENTER Birmingham, AL 35244 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-18 |
| Decision Date | 2012-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847236016081 | K121787 | 000 |
| 00847236016203 | K121787 | 000 |
| 00847236016098 | K121787 | 000 |
| 00847236009601 | K121787 | 000 |
| 00847236009618 | K121787 | 000 |
| 00847236009625 | K121787 | 000 |
| 00847236009632 | K121787 | 000 |
| 00847236009649 | K121787 | 000 |
| 00847236009656 | K121787 | 000 |
| 00847236016197 | K121787 | 000 |
| 00847236016180 | K121787 | 000 |
| 00847236016104 | K121787 | 000 |
| 00847236016111 | K121787 | 000 |
| 00847236016128 | K121787 | 000 |
| 00847236016135 | K121787 | 000 |
| 00847236016142 | K121787 | 000 |
| 00847236016159 | K121787 | 000 |
| 00847236016166 | K121787 | 000 |
| 00847236016173 | K121787 | 000 |
| 00847236009663 | K121787 | 000 |
| 00847236009670 | K121787 | 000 |
| 00847236009687 | K121787 | 000 |
| 00847236012748 | K121787 | 000 |
| 00847236012755 | K121787 | 000 |
| 00847236012762 | K121787 | 000 |
| 00847236012779 | K121787 | 000 |
| 00847236012786 | K121787 | 000 |
| 00847236012793 | K121787 | 000 |
| 00847236012809 | K121787 | 000 |
| 00847236012816 | K121787 | 000 |
| 00847236012731 | K121787 | 000 |
| 00847236012724 | K121787 | 000 |
| 00847236009694 | K121787 | 000 |
| 00847236009700 | K121787 | 000 |
| 00847236009717 | K121787 | 000 |
| 00847236009724 | K121787 | 000 |
| 00847236009731 | K121787 | 000 |
| 00847236012694 | K121787 | 000 |
| 00847236012700 | K121787 | 000 |
| 00847236012717 | K121787 | 000 |
| 00847236012823 | K121787 | 000 |