The following data is part of a premarket notification filed by Prosidyan, Inc. with the FDA for Fibergraft Bg Putty Bone Graft Substitute.
| Device ID | K143533 |
| 510k Number | K143533 |
| Device Name: | FIBERGRAFT BG PUTTY 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 1835 MARKET STREET, 29TH FLOOR 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 | 2014-12-12 |
| Decision Date | 2015-03-25 |
| Summary: | summary |