The following data is part of a premarket notification filed by Biomet3i with the FDA for 3i T3 Short Implants.
| Device ID | K150571 |
| 510k Number | K150571 |
| Device Name: | 3i T3 Short Implants |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOMET3I 4555 RIVERSIDE DRIVE Palm Beach Gardens, FL 33410 |
| Contact | Chris Mckee |
| Correspondent | Chris Mckee BIOMET3I 4555 RIVERSIDE DRIVE 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 | 2015-03-06 |
| Decision Date | 2015-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844868033660 | K150571 | 000 |
| 00844868033653 | K150571 | 000 |
| 00844868033646 | K150571 | 000 |
| 00844868033639 | K150571 | 000 |
| 00844868033622 | K150571 | 000 |
| 00844868033615 | K150571 | 000 |
| 00844868033608 | K150571 | 000 |
| 00844868033592 | K150571 | 000 |