The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Microplasty Tibial Trays.
| Device ID | K063732 |
| 510k Number | K063732 |
| Device Name: | MICROPLASTY TIBIAL TRAYS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Becky Earl |
| Correspondent | Becky Earl BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-18 |
| Decision Date | 2007-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304554498 | K063732 | 000 |
| 00880304554481 | K063732 | 000 |
| 00880304554474 | K063732 | 000 |
| 00880304554467 | K063732 | 000 |
| 00880304554450 | K063732 | 000 |
| 00880304554443 | K063732 | 000 |
| 00880304554436 | K063732 | 000 |
| 00880304009738 | K063732 | 000 |