The following data is part of a premarket notification filed by Biomet 3i, Inc. with the FDA for Osseotite Ii Model Xifossxxx.
| Device ID | K100724 |
| 510k Number | K100724 |
| Device Name: | OSSEOTITE II MODEL XIFOSSXXX |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOMET 3I, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | Jose E Cabrera |
| Correspondent | Jose E Cabrera BIOMET 3I, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-15 |
| Decision Date | 2011-04-01 |
| Summary: | summary |