The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for Biohorizons Internal Implant System.
| Device ID | K073268 |
| 510k Number | K073268 |
| Device Name: | BIOHORIZONS INTERNAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOHORIZONS IMPLANT SYSTEMS, INC. 2300 RIVERCHASE CENTER Birmingham, AL 35244 |
| Contact | Winston Greer |
| Correspondent | Winston Greer BIOHORIZONS IMPLANT SYSTEMS, INC. 2300 RIVERCHASE CENTER Birmingham, AL 35244 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-20 |
| Decision Date | 2008-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847236003760 | K073268 | 000 |
| 00847236003630 | K073268 | 000 |
| 00847236003623 | K073268 | 000 |
| 00847236003616 | K073268 | 000 |
| 00847236000417 | K073268 | 000 |
| 00847236000400 | K073268 | 000 |
| 00847236000363 | K073268 | 000 |
| 00847236000356 | K073268 | 000 |
| 00847236000318 | K073268 | 000 |
| 00847236000301 | K073268 | 000 |
| 00847236016753 | K073268 | 000 |
| 00847236003647 | K073268 | 000 |
| 00847236003654 | K073268 | 000 |
| 00847236003753 | K073268 | 000 |
| 00847236003746 | K073268 | 000 |
| 00847236003739 | K073268 | 000 |
| 00847236003722 | K073268 | 000 |
| 00847236003715 | K073268 | 000 |
| 00847236003708 | K073268 | 000 |
| 00847236003692 | K073268 | 000 |
| 00847236003685 | K073268 | 000 |
| 00847236003678 | K073268 | 000 |
| 00847236003661 | K073268 | 000 |
| 00847236016746 | K073268 | 000 |