The following data is part of a premarket notification filed by Bone Solutions, Inc. with the FDA for Osteorevive.
| Device ID | K212991 |
| 510k Number | K212991 |
| Device Name: | Osteorevive |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Bone Solutions, Inc. 5712 Colleyville Boulevard, Suite 210 Colleyville, TX 76034 |
| Contact | Drew Diaz |
| Correspondent | Kevin A Thomas PaxMed International, LLC 12264 EL Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-20 |
| Decision Date | 2022-01-21 |