The following data is part of a premarket notification filed by Biostructures, Llc with the FDA for Mcs Bone Graft.
| Device ID | K142276 |
| 510k Number | K142276 |
| Device Name: | MCS Bone Graft |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOSTRUCTURES, LLC 1201 DOVE STREET, SUITE 470 Newport Beach, CA 92660 |
| Contact | John Brunelle, Ph.d. |
| Correspondent | Patsy J. Trisler, Jd, Rac 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 | 2014-08-15 |
| Decision Date | 2015-01-16 |
| Summary: | summary |