The following data is part of a premarket notification filed by Biomet 3i with the FDA for Endobon Xenograft Granules.
| Device ID | K110449 |
| 510k Number | K110449 |
| Device Name: | ENDOBON XENOGRAFT GRANULES |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | BIOMET 3I 4555 RIVERSIDE DRIVE Palm Beach Gardens, FL 33410 |
| Contact | Martha I Garay |
| Correspondent | Martha I Garay BIOMET 3I 4555 RIVERSIDE DRIVE Palm Beach Gardens, FL 33410 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-16 |
| Decision Date | 2011-05-13 |
| Summary: | summary |