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 | K170306 |
| 510k Number | K170306 |
| 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 | 2017-01-31 |
| Decision Date | 2017-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856879006410 | K170306 | 000 |
| 00856879006816 | K170306 | 000 |
| 00856879006809 | K170306 | 000 |
| 00856879006793 | K170306 | 000 |
| 00856879006786 | K170306 | 000 |
| 00856879006779 | K170306 | 000 |
| 00856879006762 | K170306 | 000 |
| 00856879006755 | K170306 | 000 |
| 00856879006748 | K170306 | 000 |
| 00856879006823 | K170306 | 000 |
| 00856879006014 | K170306 | 000 |
| 00856879006021 | K170306 | 000 |
| 00856879006144 | K170306 | 000 |
| 00856879006120 | K170306 | 000 |
| 00856879006113 | K170306 | 000 |
| 00856879006106 | K170306 | 000 |
| 00856879006090 | K170306 | 000 |
| 00856879006083 | K170306 | 000 |
| 00856879006045 | K170306 | 000 |
| 00856879006038 | K170306 | 000 |
| 00856879006731 | K170306 | 000 |