The following data is part of a premarket notification filed by Prosidyan, Inc with the FDA for Fibergraft Bg Matrix Bone Graft Substitute.
| Device ID | K180080 |
| 510k Number | K180080 |
| Device Name: | FIBERGRAFT BG Matrix Bone Graft Substitute |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Prosidyan, Inc 30 Technology Drive Warren, NJ 07059 |
| Contact | Charanpreet S Bagga |
| Correspondent | Janice M Hogan Hogan Lovells US LLP 1735 Market Street Suite 2300 Philadelphia, PA 19103 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-10 |
| Decision Date | 2018-04-06 |
| Summary: | summary |