The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Biohorizons Tapered Internal Implants.
| Device ID | K143022 |
| 510k Number | K143022 |
| Device Name: | BioHorizons Tapered Internal 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 | 2014-10-21 |
| Decision Date | 2015-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847236011055 | K143022 | 000 |
| 00847236000462 | K143022 | 000 |
| 00847236000479 | K143022 | 000 |
| 00847236000486 | K143022 | 000 |
| 00847236009991 | K143022 | 000 |
| 00847236010003 | K143022 | 000 |
| 00847236010010 | K143022 | 000 |
| 00847236010027 | K143022 | 000 |
| 00847236010034 | K143022 | 000 |
| 00847236011048 | K143022 | 000 |
| 00847236000455 | K143022 | 000 |