The following data is part of a premarket notification filed by Ventris Medical with the FDA for Synthetic Bone Putty.
| Device ID | K221644 |
| 510k Number | K221644 |
| Device Name: | Synthetic Bone Putty |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Ventris Medical 1201 Dove Street, Suite 470 Newport Beach, CA 92660 |
| Contact | John Brunelle |
| Correspondent | John Brunelle Ventris Medical 1201 Dove Street, Suite 470 Newport Beach, CA 92660 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-06 |
| Decision Date | 2022-09-02 |