The following data is part of a premarket notification filed by Bicon, Inc. with the FDA for Bicon Bone Screw System.
| Device ID | K982488 |
| 510k Number | K982488 |
| Device Name: | BICON BONE SCREW SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BICON, INC. 1153 CENTRE ST., SUITE 21 Boston, MA 02130 |
| Contact | Vincent J Morgan |
| Correspondent | Vincent J Morgan BICON, INC. 1153 CENTRE ST., SUITE 21 Boston, MA 02130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-17 |
| Decision Date | 1999-01-26 |