The following data is part of a premarket notification filed by Biomet 3i, Inc. with the FDA for Nanotite Prevail,certain,parellel Walled,tapered,external Hex.
| Device ID | K072363 |
| 510k Number | K072363 |
| Device Name: | NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOMET 3I, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | Diana Taylor |
| Correspondent | Diana Taylor 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 | 2007-08-23 |
| Decision Date | 2008-01-31 |
| Summary: | summary |