The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Vanguard M Series Unicondylar Tibial Bearings.
| Device ID | K042093 |
| 510k Number | K042093 |
| Device Name: | VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Taacy Bickel Johnson |
| Correspondent | Taacy Bickel Johnson BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-03 |
| Decision Date | 2004-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304181021 | K042093 | 000 |
| 00880304181014 | K042093 | 000 |
| 00880304180925 | K042093 | 000 |
| 00880304180918 | K042093 | 000 |
| 00880304180727 | K042093 | 000 |
| 00880304180710 | K042093 | 000 |
| 00880304180628 | K042093 | 000 |
| 00880304180611 | K042093 | 000 |