The following data is part of a premarket notification filed by Biocomposites Ltd. with the FDA for Fortoss Vital Bone Graft Substitute.
| Device ID | K050170 |
| 510k Number | K050170 |
| Device Name: | FORTOSS VITAL BONE GRAFT SUBSTITUTE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | BIOCOMPOSITES LTD. KEELE SCIENCE PARK Keele, Staffordshire, GB St5 5nl |
| Contact | Simon Fitzer |
| Correspondent | Simon Fitzer BIOCOMPOSITES LTD. KEELE SCIENCE PARK Keele, Staffordshire, GB St5 5nl |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-26 |
| Decision Date | 2005-08-26 |
| Summary: | summary |