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 |