The following data is part of a premarket notification filed by Haider Biologics, Llc with the FDA for Sorrento Bone Graft Substitute.
| Device ID | K141429 |
| 510k Number | K141429 |
| Device Name: | SORRENTO BONE GRAFT SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | HAIDER BIOLOGICS, LLC 9930 MESA RIM DRIVE San Diego, CA 92121 |
| Contact | Gustavo R Prado |
| Correspondent | Gustavo R Prado HAIDER BIOLOGICS, LLC 9930 MESA RIM DRIVE 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 | 2014-05-30 |
| Decision Date | 2015-02-23 |
| Summary: | summary |