The following data is part of a premarket notification filed by Prosidyan, Inc with the FDA for Fibergraft Aeridyan Matrix Bone Graft Substitute.
| Device ID | K182670 |
| 510k Number | K182670 |
| Device Name: | FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Prosidyan, Inc 41 Spring St, Suite 107 New Providence, NJ 07974 |
| 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 | 2018-09-25 |
| Decision Date | 2018-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856879006311 | K182670 | 000 |
| 00856879006304 | K182670 | 000 |
| 00856879006298 | K182670 | 000 |
| 00856879006281 | K182670 | 000 |
| 00856879006250 | K182670 | 000 |