The following data is part of a premarket notification filed by Biostructures, Llc with the FDA for Mcp Bone Putty.
| Device ID | K160446 |
| 510k Number | K160446 |
| Device Name: | MCP Bone Putty |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BioStructures, LLC 1201 Dove Street, Suite 470 Newport Beach, CA 92660 |
| Contact | John Brunelle |
| Correspondent | Patty J. Trisler Trisler Consulting 5600 Wisconsin Ave Chevy Chase, MD 20815 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-17 |
| Decision Date | 2016-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816986020129 | K160446 | 000 |
| 00816986020112 | K160446 | 000 |