The following data is part of a premarket notification filed by Bone Solutions, Inc. with the FDA for Osteocrete Bone Void Filler.
| Device ID | K071004 |
| 510k Number | K071004 |
| Device Name: | OSTEOCRETE BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BONE SOLUTIONS, INC. 1205 DE LA VINA STREET Santa Barbara, CA 93101 |
| Contact | Christine Emanuel |
| Correspondent | Christine Emanuel BONE SOLUTIONS, INC. 1205 DE LA VINA STREET Santa Barbara, CA 93101 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-09 |
| Decision Date | 2009-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842528128749 | K071004 | 000 |
| 00842528128732 | K071004 | 000 |
| 00842528128725 | K071004 | 000 |
| 00842528128718 | K071004 | 000 |
| 00842528128701 | K071004 | 000 |
| 00842528128695 | K071004 | 000 |