The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Texas T - Plate.
| Device ID | K031334 |
| 510k Number | K031334 |
| Device Name: | TEXAS T - PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET, INC. 56 BELL DR. PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Gary Baker |
| Correspondent | Gary Baker BIOMET, INC. 56 BELL DR. PO BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-28 |
| Decision Date | 2003-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304249950 | K031334 | 000 |
| 00880304249875 | K031334 | 000 |
| 00880304249882 | K031334 | 000 |
| 00880304249899 | K031334 | 000 |
| 00880304249905 | K031334 | 000 |
| 00880304249912 | K031334 | 000 |
| 00880304249929 | K031334 | 000 |
| 00880304249936 | K031334 | 000 |
| 00880304249943 | K031334 | 000 |
| 00880304249851 | K031334 | 000 |