The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for The Autotac System.
| Device ID | K011675 |
| 510k Number | K011675 |
| Device Name: | THE AUTOTAC SYSTEM |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham, AL 35243 |
| Contact | Donald E Dalton |
| Correspondent | Donald E Dalton BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham, AL 35243 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-30 |
| Decision Date | 2001-06-22 |
| Summary: | summary |