The following data is part of a premarket notification filed by Bonalive Biomaterials Ltd. with the FDA for Bonalive Granules.
| Device ID | K191274 |
| 510k Number | K191274 |
| Device Name: | BonAlive Granules |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BonAlive Biomaterials Ltd. Biolinja 12 Turku, FI 20750 |
| Contact | Jimmy Lucchesi |
| Correspondent | Elisa Maldonado-holmertz Obelix Biotech Solutions 12416 Fairfax Ridge Place Austin, TX 78738 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-13 |
| Decision Date | 2019-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438132143403 | K191274 | 000 |
| 06438132143304 | K191274 | 000 |
| 06438132141409 | K191274 | 000 |
| 06438132141300 | K191274 | 000 |
| 06438132141201 | K191274 | 000 |
| 06438132141102 | K191274 | 000 |