The following data is part of a premarket notification filed by Biocomposites Ltd. with the FDA for Fortoss Vital.
| Device ID | K082383 |
| 510k Number | K082383 |
| Device Name: | FORTOSS VITAL |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | BIOCOMPOSITES LTD. KEELE SCIENCE PARK Keele, Staffordshire, GB St5 5nl |
| Contact | Marie Whalley |
| Correspondent | Marie Whalley BIOCOMPOSITES LTD. KEELE SCIENCE PARK Keele, Staffordshire, GB St5 5nl |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-19 |
| Decision Date | 2008-09-05 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FORTOSS VITAL 79371954 not registered Live/Pending |
Biocomposites Limited 2023-02-10 |