The following data is part of a premarket notification filed by Orthovita Co. with the FDA for Biogran Bioactive Glass Synthetic Bone Graft Material.
| Device ID | K952922 |
| 510k Number | K952922 |
| Device Name: | BIOGRAN BIOACTIVE GLASS SYNTHETIC BONE GRAFT MATERIAL |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | ORTHOVITA CO. 212 CARNIGIE CENTER DR. SUITE 206 Princeton, NJ 08540 |
| Contact | Thomas Becze |
| Correspondent | Thomas Becze ORTHOVITA CO. 212 CARNIGIE CENTER DR. SUITE 206 Princeton, NJ 08540 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-26 |
| Decision Date | 1995-12-19 |