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 | K171284 |
| 510k Number | K171284 |
| 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 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 | 2017-05-01 |
| Decision Date | 2017-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856879006243 | K171284 | 000 |
| 00856879006830 | K171284 | 000 |
| 00856879006847 | K171284 | 000 |
| 00856879006854 | K171284 | 000 |
| 00856879006861 | K171284 | 000 |
| 00856879006878 | K171284 | 000 |
| 00856879006151 | K171284 | 000 |
| 00856879006212 | K171284 | 000 |
| 00856879006229 | K171284 | 000 |
| 00856879006236 | K171284 | 000 |
| 00856879006526 | K171284 | 000 |