The following data is part of a premarket notification filed by Bicon, Inc. with the FDA for Synthograft.
| Device ID | K051091 | 
| 510k Number | K051091 | 
| Device Name: | SYNTHOGRAFT | 
| Classification | Bone Grafting Material, Synthetic | 
| Applicant | BICON, INC. 501 ARBORWAY Boston, MA 02130 | 
| Contact | Vincent J Morgan | 
| Correspondent | Vincent J Morgan BICON, INC. 501 ARBORWAY Boston, MA 02130 | 
| Product Code | LYC | 
| CFR Regulation Number | 872.3930 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2005-04-28 | 
| Decision Date | 2005-09-01 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SYNTHOGRAFT  77131707  3417056 Live/Registered | BICON, LLC 2007-03-15 | 
|  SYNTHOGRAFT  73406201  1272352 Dead/Cancelled | Miter, Inc. 1982-12-16 | 
|  SYNTHOGRAFT  73309369  not registered Dead/Abandoned | MITER, INC. 1981-05-08 |