The following data is part of a premarket notification filed by Xenco Medical, Llc with the FDA for Sorrento Bioglass Bone Graft Substitute.
| Device ID | K173933 |
| 510k Number | K173933 |
| Device Name: | Sorrento Bioglass Bone Graft Substitute |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Xenco Medical, LLC 9930 Mesa Rim Road San Diego, CA 92121 |
| Contact | Michelle Willis |
| Correspondent | Gustavo Prado Xenco Medical, LLC 9930 Mesa Rim Road San Diego, CA 92121 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-26 |
| Decision Date | 2018-09-13 |
| Summary: | summary |