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 |