The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Biohorizons Tapered Im Implants.
| Device ID | K182070 |
| 510k Number | K182070 |
| Device Name: | BioHorizons Tapered IM 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 | 2018-08-01 |
| Decision Date | 2018-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847236012502 | K182070 | 000 |
| 00847236012496 | K182070 | 000 |
| 00847236012489 | K182070 | 000 |
| 00847236012472 | K182070 | 000 |
| 00847236012465 | K182070 | 000 |
| 00847236012458 | K182070 | 000 |